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With $30 million in support, Brown launches Center for Alzheimer’s Disease Research – Brown University

Posted: April 29, 2021 at 1:56 am


The $25 million investment from the new centers lead donor, and the additional $5 million gift in support, mark major progress toward an initial fundraising goal of $50 million for the center and come as part of the Universitys BrownTogether campaign, which has raised $2.88 billion to date. The gifts also build on major philanthropic support for Browns cutting-edge work in brain science of the total contributed to BrownTogether to date, more than $218.3 million has been raised to support research and education in brain science, including a $100 million gift that named the Carney Institute in 2018 and a $25 million investment in January, part of which funds computational brain science.

Among the key priorities of the BrownTogether campaign is to raise funds for Brown research and discovery with the potential to transform treatment and care for people and their families living with Alzheimer's and other devastating diseases, said Sergio Gonzalez, senior vice president for advancement. These significant gifts for Alzheimer's research are a testament not only to the generous spirit of our donor community, but to their commitment to the work of Brown scholars to create solutions to the world's most pressing problems.

Among the accomplished researchers and clinicians at Brown working to solve the Alzheimers puzzle is Dr. Stephen Salloway, a professor of neurology and psychiatry who will serve as the associate director of the center, overseeing clinical research. Salloway has been a lead author on key Alzheimers studies that have been published in the Journal of the American Medical Association, the New England Journal of Medicine and more. He leads the Memory and Aging Program at Butler Hospital, a globally recognized clinical research center focused on Alzheimers, and an affiliated hospital of Browns medical school.

Stephen Salloway has been a lead author on key Alzheimers studies like this one, about a clinical trial for the drug aducanumab, which was featured on the cover of the journal Nature.

The holy grail in Alzheimers research, Salloway says, is a simple, effective, widely available blood test for early detection of the disease one that can identify who is predisposed to developing memory loss and other dementia symptoms, so that treatments can be administered as early as possible.

The gifts to Brown will aid in that quest by establishing a fully staffed fluid biomarker facility. The facility will enable researchers to collect from patients and analyze fluid biomarkers such as cerebrospinal fluid and plasma samples, identify gold-standard Alzheimers disease biomarkers, develop new hypotheses about the disease and assess the efficacy of clinical trial treatments.

Iwould like to see Brown help to open the modern era of treatment for Alzheimers disease, where patients can receive an early and accurate diagnosis and start on treatments that preserve memory and quality of life, Salloway said. We are also entering a time where older people can safely learn about their risk for Alzheimers and take steps to keep their brain healthy this center can help them do that, and the fluid biomarker facility will be an essential tool in enabling our success.

Once up and running, the facility will serve as a bridge between basic laboratory science and clinical patient-focused research, Lipscombe said. Biological and brain science research will be informed by direct access to patient-derived biomarkers and genetic data, and clinical researchers will have immediate knowledge of novel disease targets identified through basic research.

For example: A researcher might say, I think I have a biomarker, but I need to test this hypothesis. Well now have a facility with skilled scientists who can develop a laboratory test to evaluate that hypothesis and conduct additional, highly sophisticated analysis all right on the Brown campus, she said.

Funding from the gifts will also expand a partnership with a renowned translational research team led by Oskar Hansson of Lund University in Sweden. Together, the teams at Brown and Lund will study a new cohort of 500 asymptomatic individuals to identify early biomarkers of cognitive impairment and ultimately, Alzheimers disease. Hansson and his colleague Henrik Zetterberg are two of the worlds leading fluid biomarker experts and are working with Brown on the establishment of the biomarker facility.

The biomarker initiative is really a team effort, Salloway said. Brown faculty, working with researchers around the world, will help to develop combination treatments using precision medicine approaches that target key components of the disease based on the molecular profile of individual patients."

Support from the gifts will also help Brown build a critical mass of Alzheimers researchers. While Lipscombe will direct the center at its outset, the $5 million gift will contribute to the recruitment of a full-time leader dedicated to the Center for Alzheimers Disease Research. The University will also recruit key faculty in bioinformatics and neuroimmunology, two areas that will complement existing Brown expertise in biomed and brain science.

We're keen on bringing in a bioinformatics expert focused on Alzheimer's disease, dementia and neurodegeneration to identify new disease risk factors and make connections from human-derived data to basic science, Lipscombe said. And neuroimmunology is a rapidly growing field that seeks to understand the interplay between the immune and nervous systems in disease. Studying these systems is central to uncovering the origins of Alzheimer's disease.

To incentivize collaborative new Alzheimer's research projects across Browns schools, institutes, centers, departments and affiliated hospitals, a portion of the $25 million gift will be used as seed funding for new multidisciplinary efforts. The center will hold an annual competition to award funds to innovative proposals.

At Carney, weve been able to catalyze new projects and discoveries through tremendously successful innovation programs and competitions, Lipscombe said. We want to stimulate Alzheimers research much in the same way.

Nearly 60 principal investigators at Brown and its affiliated hospitals received a total of more than $40 million in federal funding for Alzheimers research in 2020 alone, earning Brown its top 20 ranking for research on the disease. And Brown-affiliated researchers are currently involved in 17 clinical trials of Alzheimers treatments, including at Rhode Island Hospital. Salloway, at Butler Hospital, and Rena Wing, a Brown professor of psychiatry and human behavior associated with the Miriam Hospital, are principal investigators of the Alzheimers Associations and NIH-funded U.S. POINTER study, a landmark clinical trial to evaluate the effect of lifestyle interventions, such as vigorous exercise, Mediterranean diet, heart health and brain training on the risk for cognitive decline. The launch of the center and the addition of new faculty and incentives for new research projects will build on a wide array of existing Brown strengths related to Alzheimers in biology and brain science, many of which are supported through that federal funding.

The new center will aim to bring together scholars leading projects in the Carney Institute, the Division of Biology and Medicine, the School of Public Health, the Department of Cognitive, Linguistics and Psychological Science (CLPS); various centers including the Center on the Biology of Aging; as well as with Butler, Rhode Island and other affiliated hospitals. Among Browns existing projects making an impact on Alzheimers and dementia:

With a grant from theAlzheimers Association, Stephen Salloway (left) and John Sedivy are leading a clinical trial of a drug that,based on Sedivy's research,may help people with Alzheimer's. Credit: David DelPoio

Each of these efforts is essential, Lipscombe notes, because the brain is composed of multiple interconnected biological systems neuronal, glial, immune and vascular and all have been implicated in Alzheimers disease and neurodegeneration. Preventing or delaying Alzheimer's disease onset will depend on an early, multifaceted treatment regime informed by target identification across these biological systems that is anchored in and informed by patient data.

Brown is uniquely positioned to cover this field from the earliest, most fundamental mechanisms all the way through to patient care, Lipscombe said. Thanks to these gifts, we have an incredible opportunity to change the disease trajectory through the Center for Alzheimers Disease Research there is no more time to waste.

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With $30 million in support, Brown launches Center for Alzheimer's Disease Research - Brown University

Boost funding for Alzheimer’s disease research – News from southeastern Connecticut – theday.com

Posted: at 1:56 am


I understand firsthand the impact Alzheimers disease has on families across America.

My husband has Alzheimers disease and MS. His vision is compromised, a combination of both diseases. He loved reading, watching TV. A brilliantly funny man, that spark is slowly disappearing.

Congressman Joe Courtney is playing an important role in addressing this critical issue.

By increasing funding for Alzheimers and dementia research at the National Institutes of Healthby $289 million we can start to win this fight. This increase in funding will mean so much to our family,our children, our grandchildren, my husbands siblings, and their children. Please join me and the Alzheimers Association in encouraging him to lead in the fight to end Alzheimers by supporting critical funding. It is only through increased research funding that we will discover new ways to treat and eventually prevent Alzheimers and other dementias.

As our nation continues its collective focus in 2021 on keeping people safe and healthy, it is time to honor the requests of scientists/researchers for additional funding so they can bring hope and optimism to the millions of American families affected by dementia.

Please help us.

Casey McGannon

Old Saybrook

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Boost funding for Alzheimer's disease research - News from southeastern Connecticut - theday.com

NC NAACP hosting Virtual Alzheimer’s and Dementia Prevention Town Hall – WXII12 Winston-Salem

Posted: at 1:56 am


Thursday, April 29, the North Carolina NAACP will be hosting a virtual town hall in partnership with the Alzheimer's Association and Wake Forest School of Medicine to focus on Alzheimer's, dementia and memory loss prevention.The panel will feature medical experts and community leaders like pastor Dr. Lamonte Williams, who is also a community liaison with Wake Forest School of Medicines Alzheimers study. He said he has seen too many parishioners go through this battle.But on the other side, Ive been very blessed to be an advocate to so many to say, listen an ounce of prevention is better than a pound of cure," Williams said. "So I want to always lift up the ability to inspire someone. "Dr. Goldy Bird is the director of the Maya Angelou Center of Equity at Wake Forest School of Medicine. She said Alzheimer's and dementia disproportionately affect communities of color. Often, she says, minorities were not always included in studies about the diseases.Two national surveys in the Facts and Figures report reveal people believe or have experienced that discrimination is a barrier to care for this disease.More than one-third of Black Americans (36%), as well as nearly one-fifth of both Hispanic Americans (18%) and Asian Americans (19%) believe discrimination would be a barrier to receiving care for Alzheimer's.COVID-19 is having a devastating impact on people with dementia and Alzheimer's disease, according to the Alzheimer's Association 2021 Alzheimer's Disease Facts and Figures Report.The report showed there were at least 42,000 more deaths across the country in 2020 compared to the averages from the previous five years, which is an increase of 16%. In North Carolina, there were 1,082 more deaths from Alzheimer's in 2020 compared to the averages of the past five years, according to the report. That's an 11.3% increase.The event will run from 6-8 p.m. Thursday night. To register to attend the event, click here.

Thursday, April 29, the North Carolina NAACP will be hosting a virtual town hall in partnership with the Alzheimer's Association and Wake Forest School of Medicine to focus on Alzheimer's, dementia and memory loss prevention.

The panel will feature medical experts and community leaders like pastor Dr. Lamonte Williams, who is also a community liaison with Wake Forest School of Medicines Alzheimers study. He said he has seen too many parishioners go through this battle.

But on the other side, Ive been very blessed to be an advocate to so many to say, listen an ounce of prevention is better than a pound of cure," Williams said. "So I want to always lift up the ability to inspire someone. "

Dr. Goldy Bird is the director of the Maya Angelou Center of Equity at Wake Forest School of Medicine. She said Alzheimer's and dementia disproportionately affect communities of color. Often, she says, minorities were not always included in studies about the diseases.

Two national surveys in the Facts and Figures report reveal people believe or have experienced that discrimination is a barrier to care for this disease.

More than one-third of Black Americans (36%), as well as nearly one-fifth of both Hispanic Americans (18%) and Asian Americans (19%) believe discrimination would be a barrier to receiving care for Alzheimer's.

COVID-19 is having a devastating impact on people with dementia and Alzheimer's disease, according to the Alzheimer's Association 2021 Alzheimer's Disease Facts and Figures Report.

The report showed there were at least 42,000 more deaths across the country in 2020 compared to the averages from the previous five years, which is an increase of 16%.

In North Carolina, there were 1,082 more deaths from Alzheimer's in 2020 compared to the averages of the past five years, according to the report. That's an 11.3% increase.

The event will run from 6-8 p.m. Thursday night. To register to attend the event, click here.

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NC NAACP hosting Virtual Alzheimer's and Dementia Prevention Town Hall - WXII12 Winston-Salem

Partnership to offer two Alzheimer’s Disease research programs – Midland Daily News

Posted: at 1:56 am


The Alzheimers Association Michigan Chapter will partner with the Michigan Alzheimer's Disease Center at the University of Michigan (MADC) to offer two research programs focused on the latest in Alzheimers research this spring.

The Michigan Chapter also will offer a variety of virtual education programs, social engagement programs and more than 100 support groups to Michigan residents in the coming months.

Were thrilled to partner with Dr. Roberts and the MADC on our upcoming research events and offer much-needed programs and support to Michigan residents, stated Jean Barnas, Alzheimers Association program services director. Unfortunately, Alzheimers is a growing burden here in Michigan and across the nation. Its so important that Michiganders know were here for them.

Upcoming featured events include:

Dementia Super Saturday Series: from 10 a.m. to noon, Saturday, May 15, Healthy Living for Your Brain and Body: Tips from the Latest Research plus a Cooking Demo: Baked Kafta with Donna Jawad from MCCFAD

The Latest Updates in Alzheimer's Disease Research with Scott Roberts, Ph.D., Michigan Alzheimer's Disease Center at the University of Michigan (MADC) from 5 to 6:30 p.m., Wednesday, May 19.

The Latest Updates in Alzheimer's Disease Research with Scott Roberts, Ph.D., Michigan Alzheimer's Disease Center at the University of Michigan (MADC) from 10 to 11:30 a.m., Friday, May 21.

Healthy Living for Your Brain and Body: Tips from the Latest Research from 7 to 8:30 p.m., Wednesday, May 26. Spanish-speaking presentation with Bingo Night

Dementia Super Saturday Series from 10 to 11:45 a.m., Saturday, June 12. Effective Communication Strategies plus an Engaging in Meaningful Activities presentation

Additional upcoming education program offerings by the Alzheimers Association Michigan Chapter include Protecting Your Brain While Living with HIV, 10 Warning Signs of Alzheimers, Legal and Financial Planning, Understanding and Responding to Dementia-Related Behaviors, and much more.

Beyond that, the association will offer a wide array of support groups and social engagement programs in May and June to provide support and help persons with dementia and their care partners find ways to remain socially active. Partnering social engagement program institutions include The Henry Ford, the Detroit Zoo, the Detroit Symphony Orchestra, the Detroit Institute of Arts, the Detroit Historical Society and more.

To learn more about and register for free education programs, support groups and social engagement programs, visit alz.org/gmc/virtual, send an email to helplinegmc@alz.org or call the Associations 24/7 Helpline at 800-272-3900.

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Partnership to offer two Alzheimer's Disease research programs - Midland Daily News

Repairing stroke and Alzheimer’s disease damage with stem cell therapy – Health Europa

Posted: at 1:55 am


The UCLA study has found that a one-time injection of an experimental stem cell therapy can promote recovery by repairing brain damage and improving memory function in mice with conditions that replicate human strokes and dementia. Dementia is characterised by an array of symptoms including problems with memory, attention, communication, and physical coordination with the two most common causes of dementia bring Alzheimers disease and white matter strokes.

The study has been published inScience Translational Medicine.

In the study, the researchers used a specialised type of glial cells which surround and support neurons in the central nervous system. Dr S. Thomas Carmichael, senior author of the study and interim director of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA and his team evaluated the effects of the glial cell therapy by injecting it into the brains of mice with brain damage similar to that seen in humans in the early to middle stages of dementia.

The therapy was developed in collaboration with Bill Lowry, a UCLA professor of molecular, cell and developmental biology. The team used a method, previously discovered by Lowry, for quickly producing large numbers of glial cells by treating human induced pluripotent stem cells with a drug called deferoxamine.

Upon injection, our cell therapy travelled to damaged areas of the brain and secreted chemicals called growth factors that stimulated the brains stem cells to launch a repair response, said Dr Irene Llorente, the papers first author and an assistant research professor of neurology at the David Geffen School of Medicine at UCLA.

This repair response limited the progression of damage, enhanced the formation of new neural connections, and increased the production of myelin, a fatty substance that covers and protects the connections.

Francesca Bosetti, a programme director at the National Institutes of Healths National Institute of Neurological Disorders and Stroke, which supported the study, said: Understanding the role that glia play in repairing white matter damage is a critically important area of research that needs to be explored. These preliminary results suggest that glial cell-based therapies may one day help combat the white matter damage that many stroke and vascular dementia patients suffer every year.

In the future, if the therapy is shown to be safe and effective through clinical trials in humans, the researchers envision it becoming an off-the-shelf product. This would mean that the cells would be mass manufactured, frozen, and shipped to hospitals, where they could be used as a one-time therapy for people with early signs of white matter stroke setting the treatment apart from patient-specific cell therapies, which are created using each individual patients own cells.

The damage from white matter strokes is progressive, so you do not have months to spend producing a treatment for each patient, said Carmichael, who is also chair of neurology at the medical school. If you can have a treatment that is already in the freezer ready to go during the window of time when it could be most effective, that is a much better option.

He added that: Because the cell therapy is not directly repairing the brain, you do not need to rely on the transplanted cells to persist in order for the treatment to be successful.

The team is now conducting the additional studies necessary to apply to the Food and Drug Administration for permission to test the therapy in a clinical trial in humans.

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Repairing stroke and Alzheimer's disease damage with stem cell therapy - Health Europa

Cognito Therapeutics touts positive Phase 2 results for device-delivered Alzheimer’s treatment – Mobihealth News

Posted: March 11, 2021 at 6:46 am


Yesterday Cognito Therapeutics, a startup using visual and auditory stimulation to treat neurodegenerative disorders, announced Phase 2 trial results suggesting its gamma frequency neuromodulation therapy slowed declines in memory andcognition among mild-to-moderate Alzheimer's disease patients.

The OVERTURE study, a multi-center, randomized controlled trial, enrolled 76 such patients aged 50 years or older beginning in 2018. These participants were randomized to receive either Cognito's audio-visual stimulation treatment or a sham stimulation for one hour each dayin their home.

Throughout the six-month treatment period, Cognito said the treatment group (n = 33) compared to the placebo group (n =20) demonstrated a significant 84% slowdown in functional decline and a significant 83% decline in cognitive impairment, as measured using standardized scales every four weeks. In addition, there was a significant61% reduction in whole brain atrophy and volumetric loss among 30 treatment group participants in comparison to 19 placebo group participants, according to the company.

"Our approach has translated into clinical proof of concept by successfully achieving statistically significant results in [Alzheimer's disease], with a potential for disease modification due to significant reduction of cerebral atrophy and volumetric loss,"Dr. Tom Megerian, chief medical officer of Cognito Therapeutics, said in a statement. "In addition to improving functional outcomes, memory and cognition, the 61% reduction in loss of whole brain volume in our Phase 2 study addresses key aspects of [Alzheimer's disease] etiology and disease progression. If these results are replicated in our larger, pivotal trial, this will represent a huge medical breakthrough in Alzheimer's research."

Outside of these top-line results, Cognito is reporting the study results this week at the 2021 AD/PD, a conference on Alzheimer's and Parkinson's diseases and related neurological disorders, and will be holding a virtual panel with executives and researchers on Friday regarding these and prior research data on the treatment.

WHAT'S THE IMPACT

Cognito's lead product is a device delivering flickering lights and other stimuli to induce gamma oscillations, a pattern of brain waves that research suggests is related to cognition. The startup licensed the technology from MIT researchers and cofounders Li-Huei Tsai and Ed Boyden, and in January of this year received a Breakthrough Device Designation from the FDA.

With these positive results, Cognito saidit will now move forward with a large-scale pivotal clinical trial of the therapy and should that effort pan out as well the FDA approval process.

"With our recent FDA Breakthrough Device Designation, we look forward to expediting the clinical development of what has the promise to be the first disease-modifying digital therapeutic in Alzheimer's disease,"CEO Brent Vaughan said in a statement.

THE LARGER TREND

Cognito which brands itself as a digital therapeutic company is joined in the Alzheimer's space by Neuroglee Therapeutics, a Singapore-based startup that raised $2.3 million in pre-seed funding in December to tackle neurodegenerative diseases with artificial intelligence, machine learning and digital biomarkers. Looking further back, Cognito's Breakthrough Device Designation was preceded by neurodegenerative digital therapeutics company Dthera Sciences, which gained the designation in 2018.

Alzheimer's and other neurodegenerative diseases have also been a focus for the broader digital health space. Sensors and software from wearables, apps and other tools have been used to spot early cases, leading Biogen and Apple to recently announce a new observational study on the subject.

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Cognito Therapeutics touts positive Phase 2 results for device-delivered Alzheimer's treatment - Mobihealth News

Language performance as a predictor of future Alzheimer’s disease – National Institute on Aging

Posted: at 6:46 am


Language sample analysis may help predict future Alzheimers disease in people who are cognitively normal, suggesting that language patterns may be an early, detectable biomarker for the disease. Published in EClinicalMedicine, researchers at IBM Thomas J. Watson Research Center and Pfizer Worldwide Research and Development analyzed written language samples and were able to predict Alzheimers disease more than seven years before the diagnosis.

For the study, researchers used data from 270 participants in the long-running, NIH-funded Framingham Heart Study: 190 participants were in the training set and 80 participants were in the test set. The training set was used to develop the linguistic markers via a type of machine learning called automated linguistic analysis. The test set, determined by those participants whose data had been reviewed thoroughly by a panel of experts to assess their Alzheimers disease status, was used to assess the predictive performance of those linguistic markers in an independent sample.

In particular, for the test set, half of the 80 subjects had developed Alzheimers-like symptoms by age 85 (cases) and half did not (controls). Each of the 270 participants had performed a written picture analysis task when they were cognitively normal. For the training set, the researchers identified 87 language characteristics from the writing samples. They then used models to predict the future development of Alzheimers disease by assessing language performance.

Researchers found that language patterns such as writing short and simple phrases, repeating and misspelling words, and skipping punctuation were associated with future onset of Alzheimers. The language pattern analysis was about 70% accurate in predicting who developed Alzheimers disease. Additionally, combining language sample analysis with more traditional clinical data models, such as neuropsychological test scores, demographic and genetic information, and medical history, increased prediction accuracy from 59% to 69% when language was also included.

The researchers noted that exploring the relationships of linguistic and non-linguistic variables, along with verbal language patterns, may further the development of non-invasive tests for the early detection of Alzheimers.

The Framingham Heart Study Consortium data used in this research was supported in part by NIA grants R01AG016495 and R01AG008122.

These activities relate to NIH's AD+ADRD Research Implementation Milestone 9.H, Launch research programs to develop and validate sensitive neuropsychological and behavioral assessment measures to detect and track the earliest clinical manifestations of AD and AD-related dementias.

Reference: Eyigoz E, et al. Linguistic markers predict onset of Alzheimers disease. EClinicalMedicine. 2020;28:100583. doi: 10.1016/j.eclinm.2020.100583.

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Language performance as a predictor of future Alzheimer's disease - National Institute on Aging

$5.9 Billion Worldwide Alzheimer’s Disease Drugs Industry to 2027 – Impact of COVID-19 on the Market – ResearchAndMarkets.com – Business Wire

Posted: at 6:46 am


DUBLIN--(BUSINESS WIRE)--The "Alzheimer's Disease Drugs - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Amid the COVID-19 crisis, the global market for Alzheimer's Disease Drugs estimated at US$ 5.9 Billion in the year 2020, is projected to reach a revised size of US$ 9.4 Billion by 2027, growing at a CAGR of 6.8% over the analysis period 2020-2027.

Cholinergic, one of the segments analyzed in the report, is projected to record a 7% CAGR and reach US$ 4.1 Billion by the end of the analysis period. After an early analysis of the business implications of the pandemic and its induced economic crisis, growth in the Memantine segment is readjusted to a revised 7.2% CAGR for the next 7-year period.

The U.S. Market is Estimated at $1.6 Billion, While China is Forecast to Grow at 10.3% CAGR

The Alzheimer's Disease Drugs market in the U.S. is estimated at US$ 1.6 Billion in the year 2020. China, the world`s second largest economy, is forecast to reach a projected market size of US$ 2 Billion by the year 2027 trailing a CAGR of 10.3% over the analysis period 2020 to 2027. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 3.7% and 6.1% respectively over the 2020-2027 period. Within Europe, Germany is forecast to grow at approximately 4.3% CAGR.

Combined Drugs Segment to Record 5.7% CAGR

In the global Combined Drugs segment, USA, Canada, Japan, China and Europe will drive the 5.2% CAGR estimated for this segment. These regional markets accounting for a combined market size of US$ 1.1 Billion in the year 2020 will reach a projected size of US$ 1.6 Billion by the close of the analysis period. China will remain among the fastest growing in this cluster of regional markets. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$ 1.3 Billion by the year 2027, while Latin America will expand at a 6.9% CAGR through the analysis period.

Select Competitors (Total 43 Featured):

Key Topics Covered:

I. METHODOLOGY

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW

2. FOCUS ON SELECT PLAYERS

3. MARKET TRENDS & DRIVERS

4. GLOBAL MARKET PERSPECTIVE

III. MARKET ANALYSIS

IV. COMPETITION

For more information about this report visit https://www.researchandmarkets.com/r/5kaxl2

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$5.9 Billion Worldwide Alzheimer's Disease Drugs Industry to 2027 - Impact of COVID-19 on the Market - ResearchAndMarkets.com - Business Wire

Report: The Growing Burden of Alzheimer’s Disease – WXPR

Posted: at 6:46 am


One out of every nine people over the age of 65 have Alzheimers disease.

In Wisconsin, that adds up to 120,000 individuals, and more than a thousand of those people live in Oneida County.

The newest report from the Alzheimers Association shows the number of people living with Alzheimers disease steadily increasing.

Julie St. Pierre, a community outreach specialist with the association, said thats because a major chunk of our population is aging.

The baby boom generation actually started reaching the age of 65 and age is the primary risk factor for developing Alzheimers disease, she said.

As more people exhibit symptoms of Alzheimers disease, the healthcare industry cant always keep up.

That includes here in the Northwoods, St. Pierre said.

Definitely receiving services in Northern Wisconsin can be a bit of a challenge. I think that we have a lot of great services in the community, she said. However, due to the large number of individuals who are in need of those services, sometimes the demand actually exceeds the capacity.

According to the Alzheimers Association, most people with Alzheimers disease are cared for by family members or neighbors.

In fact, 196,000 Wisconsinites serve as unpaid family care givers to someone with the disease.

If enough of those people needed additional care, St. Pierre said that could prove challenging to our community.

Theres a limited number of nursing homes in the Northwoods and theres an even more limited number of nursing homes that provide dementia specific care, she said. So if those individuals were not able to be at home and supported by family and friends, it would present an even more significant burden on our healthcare systems.

St. Pierre said the Alzheimers Association has many programs and services available to educate and help those dealing with Alzheimers disease.

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Report: The Growing Burden of Alzheimer's Disease - WXPR

Asceneuron Receives USD 2.2 Million Award from the Alzheimer’s Drug Discovery Foundation – PRNewswire

Posted: at 6:46 am


LAUSANNE, Switzerland and SAN FRANCISCO, March 9, 2021 /PRNewswire/ -- Asceneuron SA, an emerging leader in the development of treatments for neurodegenerative diseases,announced today the receipt of a USD 2.2 million award from the Alzheimer's Drug Discovery Foundation (ADDF) for a first in human Phase I study of the Company's next generation O-GlcNAcase inhibitor, ASN51. The trial is due to recruit healthy volunteers and Alzheimer's disease patientsat sites in Europe and Australia, to start in Q2 2021, with first interim data due in Q3 2021.

The award will support a Phase 1 single ascending dose arm and a positron emission tomography (PET) target engagement study in healthy volunteers. The Phase 1 clinical trials will assess safety and tolerability of ASN51, and closely examine multiple biomarkers relevant to the target mechanism and neurodegeneration in healthy subjects and Alzheimer's patients.

O-GlcNAcase is an emerging drug target in central nervous system (CNS) drug development since deficient glycosylation patterns of intracellular proteins have been associated with diseases of aging and neuronal dysfunction. OGlcNAcase inhibitors prevent the elimination of intracellular protein glycosylation, thereby halting the decline of the steady-state levels of this posttranslational modification. OGlcNAcase inhibitors have initially been pursued exclusively for tau-related diseases. Emerging preclinical data suggest a wider application to intracellular proteinopathies such as Alzheimer's disease and related disorders, and diseases of disturbed neuronal network function in general, with the potential to provide both disease-modifying and symptomatic benefits at the same time as multimodal drugs.

Dirk Beher, Chief Executive Officer and a Co-Founder of Asceneuron, commented:"This Phase I clinical study targeting the root cause of neurodegeneration comes at a time when our current knowledge of the biology of OGlcNAcase has reached a critical inflection point. As a leader in this field, and with the welcome support of ADDF, we plan to translate our novel and exciting biology into significant health benefits for patients with neurodegenerative diseases."

Howard Fillit, M.D., Founding Executive Director and Chief Science Officer of the ADDF, commented:

"Alzheimer's disease is a complex neurodegenerative disease, and many studies highlight the role of reducing neurodegeneration as a promising path to effective treatment. The ADDF is pleased to help advance Asceneuron's research program to test this drug candidate in Alzheimer's patients in a Phase 1 clinical trial."

Peter Van Vlasselaer, Chairman of Asceneuron added: "We're delighted to have received this substantial recognition from the ADDF for our work in neurodegeneration, and the potential of our pipeline. Together with support of the ADDF, we look to treatments for not just AD, but all and related dementias, providing new hope for the medical community, the patients, and their families / one of the greatest healthcare challenges of our time."

About Asceneuron

Asceneuron is a clinical stage biotech company focused on the development of orally bioavailable therapeutics for debilitating neurodegenerative disorders with high unmet medical need. The pipeline reflects our ambition to develop treatments for as wide a range of neurodegenerative diseases including orphan tauopathies, Alzheimer's and Parkinson's diseases. The lead program ASN120290, an O-GlcNAcase inhibitor, is being developed for the orphan tauopathy progressive supranuclear palsy (PSP). Asceneuron is also developing a next generation O-GlcNAcase inhibitor ASN51 to target Alzheimer's disease and related disorders.

Asceneuron is a privately held company financed by a renowned syndicate of investors consisting of Sofinnova Partners, M Ventures, SR One, Johnson & Johnson Innovation JJDC, Inc. (JJDC) and Kurma Partners. For more information, please visit http://www.asceneuron.com.

About the Alzheimer's Drug Discovery Foundation (ADDF)

Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, the ADDF has awarded more than $168 million to fund over 650 Alzheimer's drug discovery and biomarker programs and clinical trials in 19 countries. To learn more, please visit: http://www.alzdiscovery.org/.

SOURCE Asceneuron

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Asceneuron Receives USD 2.2 Million Award from the Alzheimer's Drug Discovery Foundation - PRNewswire

Studies explore potential, concerning connection between COVID-19 and Alzheimer’s disease – KARE11.com

Posted: February 19, 2021 at 3:52 am


According to a recent study, the number of deaths attributable to Alzheimers and dementia during the pandemic has jumped by 12% in Minnesota alone.

MINNEAPOLIS Several new studies show a possible and concerning connection between COVID-19 infections and those who already have or may develop Alzheimers and other dementia.

In fact, one study is even researching whether a COVID infection may increase a persons chance for developing dementia of which Alzheimers is the most common form down the road.

Latest studies: jump in ALZ deaths, Alzheimers patients twice as likely to contract COVID

According to data from the Centers for Disease Control and Prevention (CDC), the number of deaths attributable to Alzheimers and dementia during the pandemic has jumped by 12% in Minnesota alone. Leaders with the Alzheimers Association, Minnesota-North Dakota note the reasons for the increase among the 99,000 Minnesotans living with Alzheimers may vary but could include: reduced access to physicians and health care during the pandemic, a disruption to daily routines and care provided by family members and other caregivers, and the simple toll of social isolation.

Meantime, a recent study by Case Western University published in Alzheimers & Dementia: The Journal of the Alzheimers Association also found those with dementia have double the risk of contracting COVID-19 when compared to those without dementia. The study further noted that 20% of patients with dementia died when they contracted COVID, compared to just over 5% of people without dementia.

One big study: does getting COVID lead to dementia down the road?

But perhaps the most alarming study relates to whether a COVID infection could lead to developing dementia later in life.

It seems like large organizations, like the Alzheimers Association, have the presence of mind, no pun intended, to start looking at cognitive consequences of this disease, said Dr. Michael Rosenbloom, a behavioral neurologist and clinical director of the HealthPartners Center for Memory and Aging.

Rosenbloom noted doctors are already seeing signs of how COVID affects the brain, short-term, with patients becoming confused or having memory issues after infection. But now a new international study supported by the Alzheimers Association with technical guidance from the World Health Organization will look at the potential for COVIDs long-term effects on the brain, by following 40,000 patients from nearly 40 countries for at least two to three years.

We know that this is a virus that does have a predilection for the central nervous system. And so, for instance, it is not uncommon for patients who are infected with COVID-19, especially if theyre elderly, to present with delirium and altered mental status, Rosenbloom shared with KARE 11s Karla Hult.

Rosenbloom further noted the study builds upon an area of scientific research related to other respiratory viruses, like the 1918 influenza pandemic or severe acute respiratory syndrome (SARS). Years after those viruses attacked the global population, scientists noted an increase in other issues, including: memory problems, anxiety, and psychosis.

Doctors fear COVID-19 could leave its lasting mark by creatively attacking the brain: targeting the area of the brain responsible for both the sense of smell and short-term memory; creating blood clots that cause strokes; triggering a destructive immune response; or simply, cutting off oxygen.

If a patient has respiratory failure and the brain is deprived of oxygen, this can further impact cognition and will also have downstream consequences over time, Rosenbloom said.

The study will further compare cognitive symptoms based on the care patients received during their COVID-related illness. Scientists will also evaluate whether COVID contributes to cases of familiar dementia like Alzheimer's or if patients develop a "COVID-specific" dementia.

And while the study may not deliver initial results until early 2022, Rosenbloom and others are already braced for what the findings may mean for the current health care crisis related to Alzheimer's and other dementia.

You can imagine that we may have COVID clinics, patients post-COVID presenting with cognitive decline. And these numbers are probably going to be vast because of how infectious this disease is, and how many patients have been infected not just in the United States but throughout the world, Rosenbloom said, adding, This potentially could present a crisis for individuals or physicians in my field of work."

And on that point of concern and awareness, Rosenbloom and other neurologists have a familiar ally.

If there is a link and more people are diagnosed because they had COVID disease, it would be astronomical the cost, the financial cost. And of course, devastating, emotionally to all of us, said Sue Spalding, Chief Executive Officer of the Alzheimers Association, Minnesota-North Dakota.

Spalding noted the concern is a huge reason why the Alzheimer's Association supports the global, ongoing study and why advocates continue to encourage COVID-19 vaccinations for everyone, especially those in long-term care centers or vulnerable communities. The CDC also recommends that front-line health workers and residents and staff in long-term care settings be among the first groups to receive vaccination.

For more information on the sweeping global study, click here.

And check out alz.org for information on support or other Alzheimer's research.

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Studies explore potential, concerning connection between COVID-19 and Alzheimer's disease - KARE11.com

First-in-Human Clinical Trial to Assess Gene Therapy for Alzheimer’s Disease – UC San Diego Health

Posted: at 3:52 am


Researchers at University of California San Diego School of Medicine have launched a first-in-human Phase I clinical trial to assess the safety and efficacy of a gene therapy to deliver a key protein into the brains of persons with Alzheimers disease (AD) or Mild Cognitive Impairment (MCI), a condition that often precedes full-blown dementia.

The protein, called brain-derived neurotrophic factor or BDNF, is part of a family of growth factors found in the brain and central nervous system that support the survival of existing neurons and promote growth and differentiation of new neurons and synapses. BDNF is particularly important in brain regions susceptible to degeneration in AD.

In previous published research, principal investigator Mark Tuszynski, MD, PhD, professor of neuroscience and director of the Translational Neuroscience Institute at UC San Diego School of Medicine, and colleagues described the prevention and reversal of brain cell degeneration and death in animal models.

Mark Tuszynski, MD, PhD, professor of neuroscience and director of the Translational Neuroscience Institute at UC San Diego School of Medicine.

We found that delivering BDNF to the part of the brain that is affected earliest in Alzheimers disease the entorhinal cortex and hippocampus was able to reverse the loss of connections and to protect from ongoing cell degeneration, said Tuszynski. These benefits were observed in aged rats, aged monkeys and amyloid mice.

Amyloid mice are genetically engineered to inherit a mutation in the gene encoding the amyloid precursor protein, and as a result develop amyloid plaques aggregates of misfolded proteins in the brain that are considered a hallmark characteristic of AD.

BDNF is normally produced throughout life in the entorhinal cortex, an important memory center in the brain and one of the first places where the effects of AD typically appear in the form of short-term memory loss. Persons with AD have diminished levels of BDNF.

But BDNF is not easy to work with. It is a large molecule and cannot pass through the blood-brain barrier. As a result, researchers will use gene therapy in which a harmless adeno-associated virus (AAV2) is modified to carry the BDNF gene and injected directly into targeted regions of the brain, where researchers hope it will prompt production of therapeutic BDNF in nearby cells.

The injections are precisely controlled to contain exposure to surrounding degenerating neurons since freely circulating BDNF can cause adverse effects, such as seizures.

The three-year-long trial will recruit 12 participants with either diagnosed AD or MCI to receive AAV2-BDNF treatment, with another 12 persons serving as comparative controls over that period.

This is the first safety and efficacy assessment of AAV2-BDNF in humans. A previous gene therapy trial from 2001 to 2012 using AAV2 and a different protein called nerve growth factor (NGF) found heightened growth, axonal sprouting and activation of functional markers in the brains of participants.

The BDNF gene therapy trial in AD represents an advance over the earlier NGF trial, said Tuszynski. BDNF is a more potent growth factor than NGF for neural circuits that degenerate in AD. In addition, new methods for delivering BDNF will more effectively deliver and distribute it into the entorhinal cortex and hippocampus.

Despite billions of dollars of research investment and decades of effort, there are only two symptomatic treatments for AD. There is no cure or approved way to slow or stop progression of the neurological disorder that afflicts more than 5 million Americans and is the sixth leading cause of death in the United States.

Numerous clinical trials are ongoing to assess pharmaceutical remedies. Tuszynski said gene therapy, which debuted in 1980 and has been tested on multiple diseases and conditions, represents a different approach to a disease that requires new ways of thinking about the disease and new attempts at treatments.

We hope to build on recent successes of gene therapy in other diseases, including a breakthrough success in the treatment of congenital weakness in infants (spinal muscular atrophy) and blindness (Leber Hereditary Optic Neuropathy, a form of retinitis pigmentosa), Tuszynski said.

BDNF gene therapy has the potential, unlike other AD therapies currently under development, to rebuild brain circuits, slow cell loss and stimulate cell function. We are looking forward to observing the effects of this new effort in patients with AD and MCI.

For more information on this Phase I clinical trial, contact Michelle Mendoza at 858-249-3015 or email alphastemcellclinic@ucsd.edu

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First-in-Human Clinical Trial to Assess Gene Therapy for Alzheimer's Disease - UC San Diego Health

SciSparc to Conduct a Phase IIa Clinical Trial in Alzheimer’s Patients Using the Company’s Proprietary Cannabinoid-Based Treatment – PRNewswire

Posted: at 3:52 am


TEL AVIV, Israel, Feb. 17, 2021 /PRNewswire/ --SciSparc Ltd. (formerly known as Therapix Biosciences Ltd.) (OTCQB: SPRCY) a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced it has signed an agreement with The Israeli Medical Center for Alzheimer's, to conduct a phase IIa clinical trial to evaluate the safety, tolerability and efficacy of SCI-110 (formerly THX-110) in patients with Alzheimer's disease and agitation using the Company's proprietary cannabinoid-based technology.

The study's primary objective is the safety of SCI-110 and the secondary objective is the ability of the compound to ameliorate agitation and other behavioral disturbances in patients with Alzheimer's disease.

The study will be initiated immediately after receipt of all the required approvals from the Institutional Review Boards(IRB) and the Israeli Ministry of Health (MoH).

The study, titled "Clinical Study Protocol Phase II-a open label trial to evaluate the safety, tolerability and efficacy trend of SCI-110 in patients with Alzheimer's Disease and agitation," will be conducted under the leadership of Dr. Alona Raveh, MD, Principal Investigator and board-certified geriatrician.

The drug product, SCI-110, is a unique proprietary combination of Dronabinol (synthetic delta-9-tetrahydrocannabinol (-THC), and Palmitoylethanolamide (PEA).

Alzheimer's disease is the most common type of dementia, accounting for over two-thirds of cases of dementia. Alzheimer's disease is a neurodegenerative disease that causes progressive and disabling impairment of cognitive functions including memory, comprehension, language, attention, reasoning and judgment. Symptoms of Alzheimer's disease depend on the stage of the disease. Neuropsychiatric symptoms like apathy, social withdrawal, disinhibition, agitation, psychosis, insomnia, poor appetite and wandering are also common in the mid to late stages.

The current pharmacological treatment of agitation in Alzheimer's disease has an unsatisfactory benefit/risk ratio and often involves using off-label drugs. Antipsychotic drugs, which are the most frequently used drugs for this purpose, are only marginally better than placebo.

"As the population of the world continues to age, Alzheimer's disease is one of the most common diseases affecting the elderly. Alzheimer's disease is frequently associated with neuropsychiatric symptoms such as agitation and aggression, especially in the severe stages of the illness. However, the limited efficacy and high-risk profiles of current pharmacotherapies for the management of agitation and aggression in Alzheimer's disease left us, the caregivers, with no good treatment alternatives. We are always in the search for new, innovative treatment solutions, and I hope SCI-110 may represent such a solution," said Nitai Eliash, the Chief Executive Officer of the Israeli Medical Center for Alzheimer's, where the trial will take place.

"We believe there is strong scientific rationale for exploring SCI-110 in patients with Alzheimer's disease and agitation and we appreciate very much the collaboration and opportunity to study our innovative proprietary drug candidate, SCI-110, at the leading center in Israel for the treatment of Alzheimer's disease patients," stated Dr. Adi Zuloff-Shani, PhD, Chief Technology Officer of SciSparc.

About SciSparc (OTCQB:SPRCY):

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 (formerly THX-110) for the treatment of Tourette syndrome and for the treatment of obstructive sleep apnea; SCI-160 (formerly THX-160) for the treatment of pain; and SCI-210 (formerly THX-210) for the treatment of autism spectrum disorder and epilepsy.

About The Israeli Medical Center for Alzheimer's:

The Israeli Medical Center for Alzheimer's (IMCA) is the only medical center in Israel exclusively devoted to the treatment of Alzheimer's disease patients. IMCA was founded in 1994 as a public, not for profit foundation, and in July 2001 it opened as an active medical center. The Alzheimer's center treats hundreds of patients a year, as inpatients, outpatients and as part of its diagnosis and counseling services. Numerous studies are conducted at the center in collaboration with researchers at universities.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses expectations regarding the potential for approvals needed for the initiation of the Phase IIa study, the safety of SCI-110 and the ability of SCI-110 to treat Alzheimer's disease. The transaction described here may never be consummated and definitive agreement(s) may not be executed, and, if executed, such agreement(s) may be subject to conditions before it can be completed. In addition, the market for products contemplated by the letter of intent is in a period of regulatory and business uncertainty and financial and business results from such businesses are uncertain. Historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on June 15, 2020, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investor Contact:[emailprotected] Tel: +972-3-6167055

SOURCE SciSparc Ltd.

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SciSparc to Conduct a Phase IIa Clinical Trial in Alzheimer's Patients Using the Company's Proprietary Cannabinoid-Based Treatment - PRNewswire

Alzheimers Q&A: Are massage or touch therapies beneficial for those with Alzheimer’s disease? – The Advocate

Posted: at 3:52 am


No treatment plan is perfect for those with Alzheimers disease, but massage/touch therapies can provide viable interventions and increase quality of life, curb and calm disruptive behaviors, improve blood circulation levels and generally lift an affected person's spirits.

Scientists and studies have long found that people of all ages who are regularly touched tend to be less anxious, recover from illness more quickly and feel safer and more nurtured.

Some research has found that for those with Alzheimers, human touch plays an integral role in promoting overall well-being. Just five minutes of hand massage, for instance, can induce a physical relaxation response and reduce levels of cortisol, a hormone released during times of stress.

Massage/touch therapy has also been found to raise levels of serotonin, a neurochemical that promotes feelings of calm and reduces anxiety.

Massage and touch have been suggested as nonpharmacological interventions to reduce and/or manage a range of conditions associated with Alzheimers and dementia-related disorders, such as anxiety, agitated behaviors and depression. However, because the research is so limited in scope, it is not possible to draw general conclusions about the benefits of these therapies for those with these conditions.

Some studies have found that using calming music and hand massage reduced verbal agitation, a benefit sustained for up to one hour. Another study found that hand massage/touch therapies were somewhat beneficial in agitatedindividuals. Hand massages were given for five minutes in the mornings and afternoons for 10 days, and results showed these interventions decreased the frequency and intensity of agitated behaviors during morning care routines, but not during evening care.

People with Alzheimers disease dont lose the capacity for human emotion or recognition of a caring touch. There are several benefits massage therapy offers people with Alzheimers disease, including increased body awareness and alertness, as well as a reduction in the feelings of confusion and anxiety. You also build reassurance and trust and help calm agitation, said Ann Catlin, founder of the Center for Compassionate Touch and an expert in the field of massage therapy in elder care and hospice.

Additionally, Catlin said she believes massage therapy can also help ease the effects of isolation, loneliness and boredom while encouraging feelings of worthiness and well-being.

While some people with Alzheimer's respond well to being touched or having their hands massaged, others could have a negative response. Some connect it to long-term memories of emotional or physical pain. Therefore, such therapies need to be applied on an individual basis.

Questions about Alzheimer's disease or related disorders can be sent to Dana Territo, the Memory Whisperer, owner of Dana Territo Consulting, LLC, at thememorywhisperer@gmail.com.

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Alzheimers Q&A: Are massage or touch therapies beneficial for those with Alzheimer's disease? - The Advocate

Study finds apples reduce risk of Alzheimer’s disease – Know 5 other health benefits of the nutritious fruit – Times Now

Posted: at 3:52 am


Study finds apples reduce risk of Alzheimer's disease - Know 5 other health benefits of the nutritious fruit  |  Photo Credit: iStock Images

New Delhi: If someone has not heard the saying An apple a day, keeps the doctor away in their whole life, they have probably been living under a rock, or may be on another planet. Apples have been touted as one of the best fruits to add to your diet, and for all the right reasons. While apples have many health benefits, researchers have recently found that the nutritious fruit may be extremely healthy for the brain, and even reduce the risk of brain disorders such as Alzheimer's disease.

According to the study, natural compounds found in apples can reduce the risk of developing Alzheimer's disease, and even other forms of dementia. High concentrations of phytonutrients found in the fruit help in the creation of neurons, a process that is called neurogenesis. Neurons are a highly excitable cell that transmits information to parts of the body via electrical signals and they boost our learning and memory abilities. Two compounds quercetin in apple peel and dihydroxy benzoic acid (DHBA) in apple flesh generated neurons. The experiment was found to have a positive result in the brains of mice.

However, it was found that apple juice did not significantly contribute to neurogenesis, suggesting the benefits apply to eating the whole apple and not just a glass of juice.

Disclaimer: Tips and suggestions mentioned in the article are for general information purpose only and should not be construed as professional medical advice. Always consult your doctor or a dietician before starting any fitness programme or making any changes to your diet.

Get the Latest health news, healthy diet, weight loss, Yoga, and fitness tips, more updates on Times Now

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Study finds apples reduce risk of Alzheimer's disease - Know 5 other health benefits of the nutritious fruit - Times Now

Online Seminar To Examine Health Disparities and Alzheimer’s – WHMI

Posted: at 3:52 am


By Jon King / jking@whmi.com

A virtual seminar next month will feature some of the nations top experts in the field of health equity and Alzheimers disease.

The Alzheimers Association is hosting the virtual Dr. James S. Jackson Seminar on Health Equity and Alzheimer's Disease on Wednesday, March 3rd from 5 - 6:30pm. Named in honor of the late-Dr. James Jacksons research at the University of Michigan, it will feature the latest research involving underserved communities, bringing together some of the nations top experts in the field of health equity and Alzheimers disease.

According to the Alzheimers Association, COVID-19 has laid bare some undesirable truths: underserved communities are disproportionately impacted by the pandemic adding that In the field of Alzheimers and dementia, statistics point to a similar troubling trend. The Association says the event is particularly timely with new research from Case Western Reserve University showing African Americans with dementia have close to three times the risk of being infected with COVID-19 as white individuals with dementia.

Jennifer Lepard, Alzheimers Association Michigan Chapter president and CEO said that while their goal is to work toward a world without Alzheimers and all other dementia, they cant do that without listening to and understanding the needs of diverse communities locally. Registration details for the March 3rd seminar are available online at alz.org/jackson-seminar.

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Online Seminar To Examine Health Disparities and Alzheimer's - WHMI

The Problem of Alzheimer’s: A Podcast with Jason Karlawish – GeriPal – A Geriatrics and Palliative Care Blog

Posted: at 3:52 am


Where are we with Alzheimers? Are we about to see a revolution in how we diagnose and treat it with Amyloid PET scans and the amyloid antibody aducanumab (which is currently on FDAs desk for approval)? Or are we still in the same place where there is no meaningfully effective treatment? Or is it somewhere in between, given the data that we have on comprehensive dementia care?

We talk today with Jason Karlawish, a professor of medicine, medical ethics and health policy, and neurology at the University of Pennsylvania Perelman School of Medicine. In addition to being a geriatrician extraordinaire, he is the author of the new book The Problem of Alzheimers: How Science, Culture, and Politics Turned a Rare Disease into a Crisis and What We Can Do About It.

In addition to talking about PET scans and new drugs like aducanumab, we discuss with Jason about the history of Alzheimers, the history of how we care for and fund caregivers, and where we go from here.

So take a listen and check out Jasons book!

You can also find us onYoutube!

Listen to GeriPal Podcasts on:

TRANSCRIPT

Alex: This is Alex Smith.

Eric: And, Alex, who is our guest today?

Alex: We are delighted to welcome to the GeriPal Podcast Jason Karlawish, who is a geriatrician and is Co-Director of the Penn Memory Center and a Professor of Medicine at the University of Pennsylvania, Perelman School of Medicine. Welcome to the GeriPal Podcast, Jason.

Jason: Thank you. Great to be here, Alex and Eric.

Eric: It's great to have you. Alex and I just finished reading your book, The Problem of Alzheimer's, and we're really excited to talk to you about it. It is really a truly wonderful book. So very researched with stories that I've never heard about before, about the history of Alzheimer's, the history of geriatrics. It is quite amazing. But before we get on that topic, we always start off with a song request. Do you have a song for Alex?

Jason: I do. Robert Johnson, Sweet Home Chicago.

Alex: And why this song?

Jason: Two reasons: one personal and the other ties to the book, believe it or not. Personal, I came of age in Chicago. It's where I went to college and then I went to medical school and then came back for fellowship, and critical points in my personal and my academic intellectual development were in Chicago. So it's really just my sweet home.

Jason: But also Robert Johnson, an interesting story, kind of forgotten, kind of disappeared from the scene, but then rediscovered. Kind of like Alzheimer's disease, nearly forgotten, but then rediscovered. So I just thought it had a nice symmetry.

Alex: That's great. Here's a little bit. (singing)

Jason: All right.

Eric: That was awesome. I can't believe Ken Kovinsky hasn't yet made us do that song.

Alex: No, he did. We did that on our first podcast.

Alex: That was better than the first podcast, but I still am not good at the blues. That's good. I hope. People, if you're listening and you're a future guest, please request the blues because I will get better over time, I promise.

Eric: Jason, again, thank you. First of all, where can people find this book?

Jason: So The Problem of Alzheimer's: How Science, Culture, and Politics Turned a Rare Disease into a Crisis and What We Can Do About It is available in hardback, in Kindle/e-book, and in audio book, wherever fine hardback, Kindle/e-book, audio books are sold.

Jason: Bound, please, if you can, but also your local bookstore, Amazon, yada, yada, St. Martin's Press, a division of Macmillan. If you get the audio book, you get to listen to me read the opening chapter and the closing chapter. In between is an actor.

Eric: Nice. I've got to start off by asking, because we had a fair amount of authors come on our show. We talked about their books. This was incredibly detailed. The amount of references and the stories and going into the history, we're going to go through all of that. It must have been ... This is your second book. How did you decide, "I'm going to write a book on the problem with Alzheimer's"?

Jason: The idea had been gestating, germinating, pick your odd biological metaphor, for probably a decade, and I'm so glad I didn't write it when I first thought of it, because I really had to arrive at this book the way it was done. A lot of attention in creating it was how much is this book about me as a doctor of Alzheimer's care versus about the disease, and I finally think I arrived at that reconciliation.

Jason: It's interesting, the working titles for the book originally was My Profession: Confessions of an Alzheimer's Doctor, a wonderful play on profession and confession. That helped move it along. Then I'm like, "No, no, no." Then it was called The House of Alzheimer's to capture this construction of the disease, if you will, dare I say social construction, and that didn't work, actually. That hung on for a while.

Jason: Then it was called The Disease of the Century. Then I was at a party during the pandemic, a small party, socially gathered. Very socially gathered. I told something about the book and they said, "Oh, it's about COVID, the disease of the century."

Eric: COVID screws up everything, man.

Jason: I know. But then this is the title, The Problem of ... Anyway, so it was a journey to get to that ... Those titles, I think, showed the journey of getting to the book as it is now. I agree, the observation with the prior book and this book are both heavy with using history as a means to tell a story. I dare would never call myself a historian, just like a historian doesn't call themselves a neurosurgeon. But many neurosurgeons like to become historians, but that's another story.

Eric: Then taking another step back, even before the book, why Alzheimer's? Why is this such an important issue? I mean there are a lot of problems in geriatrics, caring for older adults, in medicine. Is there something that drew you to Alzheimer's?

Jason: Yeah. I lay that out in the book. In part three, I bring things up to present time and put myself into it and a bit of the story how I moved from critical care to geriatrics, and then within geriatrics made Alzheimer's the focus. Some of that's personal, events around the destructive care that my grandfather received, and some of it's academic, namely long-standing interest in issues of ethics and human values.

Jason: If you had to pick the one specialty, I would argue, that most brings those things together, it's geriatrics. It's certainly in the top, I think. Then if you had to pick the one disease within geriatric syndrome, it's dementia.

Jason: And so, for me, it was, has been, and I think, for a while, at least it's going to remain the focus that allows me to do what I like to do across all those areas.

Eric: Yeah. Alex, before we're talking on the four sections, any other questions that you have?

Alex: I just want to say that I also agree this is a tremendous book. Really enjoyed reading it. So delighted to see familiar characters in it, including yourself, of course. But also Mike Weiner, who's at the VA in San Francisco, where Eric and I practice, and Rita Redberg, who is a professor of cardiology at UCSF and played an integral role in steering this committee about should we be screening for Alzheimer's with amyloid PET scans, and Steve Pearson, who was my residency director and is now head of ICER, Institute for Clinical Effectiveness Research, of which I'm a part and have a meeting on Thursday, as well as just learning all of this tremendous history about the formation of Alzheimer's Association, policy changes. We're going to get into some of this now.

Alex: But also very different from your prior book, Open Wound: The Tragic Obsession of Dr. William Beaumont, which I read and we reviewed on GeriPal previously ... I think Dan Matlock wrote that review ... which was much more of a historical, fictional account, whereas this is nonfiction.

Jason: This is definitely nonfiction.

Alex: This is much more similar to being mortal, with more history, but still including the personal stories which bring it home and make it very particular and specific for the readers. So kudos to you on writing this, and we should launch into it.

Jason: All right.

Eric: All right. We're going to break it down by section. The first section, and correct me if I'm wrong on any of this, is really the changing meaning and definition of Alzheimer's disease. Again, really encourage, if people want more in depth, really do read this book if you're interested in Alzheimer's disease or the history of dementia, history of geriatrics. It's like it's all in there.

Eric: But I'm going to start off with one quote, where you actually ... You tell one of your patients' wives that, "Mr. Harrison pushed back when I labeled his wife as mild stage. 'Her anger was so disruptive, this had to be severe,' he continued. The counter severity of the emotional behavioral problems are not factored into staging."

Eric: I'm just going to stop there. It was really lovely written. It was the first time I thought, "Oh, yeah." When I say mild disease, I'm thinking it from my medical lens, but there are so many other lenses including like from a personal perspective for this husband. "It's not mild. It's taking all of my resources."

Jason: Exactly, yeah. So it must be severe, yeah. Yeah, I know. Part One: Alzheimer's Unbound is all about the changing meanings, emphasis on meanings, plural. The particular quote that you pulled there was this husband who ... I'm staging the disease by the way we're supposed to, which is the severity of impairments and IADLs and then BADLs. We don't put behavior into that because it waxes and wanes, as we know.

Jason: And yet for him, it was all about the severity of her anger, which made the disease, at least we would say, so I think subjectively, ethically, if you will, severe. That theme runs through that part, which is how do you see what is this disease and, therefore, what do you talk about when you talk about Alzheimer's? Much of it, of course, Alzheimer's Unbound, about how the professional community has had its changing meanings.

Jason: I started out with the view ... I was trained in the dementia and then is it Alzheimer's. I realized as I wrote the book that I occupied personally, this transformative period where we want from you must go through the door of dementia to enter the house of Alzheimer's to now this unbound sense of what Alzheimer's is where you don't have to have any clinical problems, if you will, to be labeled with it.

Jason: And so, that's what that part's about. We truly, I mean you guys too, have lived through that revolution and redefinition and recasting of the disease and all the messiness that follows from that.

Eric: Well, let's talk about that. So what does it take to get a label of Alzheimer's disease now?

Jason: I think now it depends on where you go, and I don't mean that flippantly. But if you think of the disease the way that the field is transformed, and I talk about that in the Republic of Alzheimer's Disease, the chapter about this coalescing of the biomarker revolution into a recasting of the disease as a biomarker, biological diagnosis akin to cancer, et cetera. There's a lot of logic to that for many reasons that are commendable.

Jason: But what that does is it unlimbers the disease from many clinical correlation, any clinical reality. If you had to pick one disease that was so hard bound to clinical care, it was Alzheimer's. You had to have dementia.

Jason: Of course, there's that interregnum period of mild cognitive impairment where you don't have dementia, but you're not normal anymore. You're in the middle. That's one other way to define what Alzheimer's is. That is to say the clinical state of MCI or dementia caused by Alzheimer's. Or maybe never mind that, that's just the syndromic staging and it's all about the biology.

Jason: My point is that I wanted to put the origins of all those streams of thought out there. How did we get to them and what have been the controversies that surround them now and going forward?

Eric: Yeah. One big controversy right now is when we think about ... I'd love to talk about this thinking about Alzheimer's disease before it gets clinical, but how and whether or not new imaging, like amyloid PET scans, are really changing the way we're thinking about it or should think about it, or is it still very much in the it needs to be in certain centers is, it's very much a research-

Jason: Alex mentioned Dr. Redberg, who's at your institution. I think one of the high-low moments in the modern history of Alzheimer's was the committee that she chaired, the MEDCAC committee, the Medicare Advisory Committee on Coverage or whatever it is. It's this committee that's charged with advising CMS, the Centers for Medicare & Medicaid Services about the evidence to support covering something.

Jason: And so, Eli Lilly brings the first commercially available amyloid radio tracer for their review, and hopefully their agreement, that the evidence is sufficient to support its use in clinical practice. I got the transcript to that hearing. It's publicly available. You have to have the patience to read it.

Jason: And it was a disaster. That is to say from the perspective of Lilly. I mean it is a fascinating ... Someone ought to make a play out of it, because you witness this coming together of the biomarker Alzheimer's field with the wider field of medicine ... And these were smart people, I mean Redberg and others. These were not off-the-street, I-don't ... I mean they knew the science, and they could not convince the one and the other ... In particular the Alzheimer's field, could not convince the wider smart field of medicine that this is a test you should use in clinical practice.

Jason: It's this interesting moment where ... I don't want to say two cultures, but two ways of thinking about the disease cannot come together. It ends with the committee voting that the evidence is not sufficient to support its use in clinical practice.

Jason: What's interesting, of course, is that that was a day in January where it was preternaturally warm in Baltimore and there was a thunderstorm at the end of the day, which there used to be an expression "thunder in the winter" or something. It's impossible until global warming, of course. Just to me, that just captured how unusual that day ... The sort of oddities of that day.

Jason: But, simply, it shows how difficult it has been and remains to translate this biomarker-based definition into wide clinical practice, and that hearing laid it all out.

Eric: Yeah, I can imagine the challenges. A, you'd have to show it actually significantly changes management or what happens. B, it also links the biomarker, let's say amyloid, to the disease. Later on, I think in section three, you also talk about, maybe it was before, the heterogeneity. There is a lot of differences. How sure are we ... Like everything that we're seeing is related to this biomarker, which is amyloid. How do you put the-

Jason: Well, the funny thing about that hearing was that they went in with the argument that for people with mild cognitive impairment, this test is really good. They were right and they were wrong. They were right because if you come to my Penn Memory Center and I spend the effort and time to figure out that you truly have mild cognitive impairment, and I walk you through imaging, I can see the value of an amyloid scan in your case to figure you out.

Jason: But that's at a Penn Memory Center where we have the ability to do that kind of work up. MCI is this fragile little bird in the spring, that out in the wide world, it just can't survive, namely you put MCI out in the ... And this is what I think Redberg and rest were on to, which is they're not going to figure out MCI ...

Eric: Yeah. You have your 50-year-old who's going to come to your clinic. You're just going to order your PET amyloid for everybody.

Jason: Exactly.

Eric: Oh, PET amyloid's positive. Oh, my goodness.

Jason: That's what they figured out and that's what the field ... And that still remains today that we have this idea of MCI which works well if you come to a place like Penn or the Mayo Clinic, where it was discovered. But in wide clinical practice remains this mysterious protean, "I guess you've got MCI if you've got a memory complaint," or, "I don't want to have to stay you have Alzheimer's disease."

Jason: And so, that's one problem. Then, of course, the other problem is the more we understand the biology of the disease, the more complex we see it as, that is to say the discoveries of things like TDP-43, vascular disease, ubiquitin. This is not one disease. It's many disease. It's best thought as Alzheimer's diseases. And that's what the science has arrived at now.

Eric: Yeah. I love that analogy you also make with cancer. You can't think of cancer as one disease. I also think it's interesting when we think about it, because it links to ... Medicine really loves defining people with pre-diseases, like prediabetes.

Eric: That great paper that just came out in JAMA Internal Medicine on prediabetes with editorial on that, basically showing that a lot of people with prediabetes ... More people convert to normal than convert to diabetes-

Alex: Among older adults.

Eric: Among older adults. Sorry. Thank you, Alex. What's the title of that editorial, Alex, again? I love that title.

Eric: Yeah. It was like Two Risk Factors Removed or something. I think a lot of the worry is when we're doing around PET MRIs, what are we actually measuring here? I'd just love, Jason, for my own knowledge, like let's say you have somebody in your memory clinic. So you've got the expertise now. Somebody comes in with an MCI, you do this PET scan. How many people will actually ... Like not everybody with a positive PET will develop dementia over three years, most. Where are we with the knowledge around ...

Jason: So in locally classified amnestic MCI, where you also see neurogeneration, meaning evidence of atrophy on MRI, and then add to that not just amyloid, but a tau marker, you've got pretty good prognostic ability that, over five years, they're going to experience cognitive decline.

Jason: Having said that, though, and to get to the label of MCI, as I point out in the book, is tremendously challenging. The folks at the Mayo Clinic had the luxury of the Mayo medical record, the Mayo system to really figure that out, and wide clinical practice that's so fungible.

Jason: But where the field will go is much like in cancer and cardiovascular disease. Where there is a drug, a treatment, it will help define the disease. So there will be some sort of druggable and, therefore, that'll be a definition of the druggable form of Alzheimer's.

Jason: You see that in the history of MS as well. As MS treatments were developed for multiple sclerosis, it carved out different kinds of MS that responded more or less differently to the various treatments that were developed since beta interferon in the early '90s.

Jason: So I mean I think the future for this disease is more or less druggable targets based on various different biological measures. Where? I think the bottom line will be the bottom line, which is what's the return on this expense in terms of delaying disability, et cetera?

Eric: Don't we have a druggable target, Aricept, memantine, Namenda?

Jason: No, those drugs were developed to develop a research infrastructure. I had a lot of fun on the part of the book called The Birth of Alzheimer's. It ends with hope in a pill. Hope in a pill is the story of the cholinesterase inhibitors.

Eric: I love that chapter, by the way.

Jason: Yeah. Ken Covinsky gets quoted in that.

Eric: It was so great just to learn the history of tacrine and all of these things as a geriatrician. I've never prescribed tacrine. I've heard about it, and it was great just to see like how it actually developed over time.

Jason: Yeah, the story on the cholinesterase inhibitors is one that I think ought not to be forgotten. I'm afraid it's being a little bit repeated now with the story about aducanumab that's under FDA review as we speak.

Jason: But essentially there was great hope, promise, and desire for something that worked. Unfortunately, there's nothing like those kind of emotions in people who can't admit their emotions to compel those people to do things. So the scientific community really went over the top on the benefits of the cholinesterase inhibitors, publishing in New England Journal in an editorial that said it was a triumph for the scientific method, et cetera.

Jason: Ultimately, the study that got tacrine going was found essentially to be fraudulent. They didn't know that at the time they published the story, the research report, but the NEJM editors would subsequently admit that they had concerns about the design of the study.

Jason: The point I try to bring out in that section was you've got an awful disease, no treatments, a desire to show progress. That's a dangerous brew to make bad decisions, especially if your culture is we can't admit the emotional aspects that drive us. [crosstalk 00:22:48].

Alex: Right.

Eric: I feel like you linked later to ... What's the antibody called again? Ada-something.

Jason: Oh, aducanumab.

Eric: There you go. I could never remember those names. Basically, that story of that drug seem to perfectly mimic the story of what was happening-

Jason: There are strange parallels between current events and past events. No surprise.

Eric: Yeah. Maybe we can figure out, tease out some statistical significant differences if you ... Maybe tease around the numbers a little bit. But what's the clinical benefit of it? It seemed like that was a potential question that's happening right now. Is that right?

Jason: It is. That is a very pithy summary. One of the things I talk about in the hope in a pill and that chapter is the difficulty that began in the cholinergic hypothesis era, and still persist today, of having a coherent, understandable language to talk about how have we successfully treated this disease. It's very different than cancer or cardiovascular disease, where in the end, it's are you alive or dead, because death in this disease is something that is not an end point we want to delay. We have a very weird relationship with death with this disease.

Alex: Yeah. Is there anything more that we want to talk about with imaging? Because I want to ask a little bit more about treatment, which we've moved into. Eric, did you want to mention the oculo-prescriptive reflex, or should we skip over that?

Eric: No, I'm going to skip over that. I've got some backlash over that.

Alex: Let's skip that one.

Eric: I think the main thing is-

Alex: Listeners, you can figure out what that might mean [laughter]. You see something on amyloid and that leads to a prescription.

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The Problem of Alzheimer's: A Podcast with Jason Karlawish - GeriPal - A Geriatrics and Palliative Care Blog

Cassava Sciences Announces Significant Program Progress and Expected Key Milestones in 2021 for Its Clinical Program in Alzheimer’s Disease -…

Posted: February 9, 2021 at 6:55 pm


AUSTIN, Texas, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company developing product candidates for Alzheimers disease, today announced significant program progress and expected milestones for 2021.

We started 2021 with tremendous momentum, led by results of a 6-month interim analysis from an open-label study of simufilam, our drug candidate for Alzheimers disease, said Remi Barbier, President & CEO. I believe the rest of the year may be equally exciting.

Cassava Sciences strategic focus for 2021 is to advance simufilam in a Phase 3 clinical program in Alzheimers disease, to expand drug manufacturing capabilities in support of the clinical program, and to continue to lead the Company to deliver the full potential of its product portfolio.

Cassava Sciences 2021 Scientific and Clinical OutlookCassava Sciences product portfolio includes a small molecule drug for the treatment of Alzheimers disease, called simufilam, and an investigational blood-based diagnostic to detect and monitor the progression of Alzheimers disease, called SavaDx.

Expected progress and key milestones in 2021 across Cassava Sciences product portfolio are summarized below.

Other Expected Milestones and Announcements for 2021

Slide DeckA copy of Cassava Sciences latest corporate presentation is available on its website https://www.CassavaSciences.com, under the Investors/Presentations page.

About Alzheimer's Disease Alzheimers disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimers disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimers disease, and approximately 487,000 people age 65 or older developed Alzheimers in 2019.1 The number of people living with Alzheimers disease is expected to grow dramatically in the years ahead, resulting in a growing social and economic burden.2

About SimufilamSimufilam is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimers pathology, neurodegeneration and neuroinflammation. The underlying science for simufilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimers Disease.

Cassava Sciences is also developing an investigational diagnostic, called SavaDx, to detect Alzheimers disease with a simple blood test.Simufilam and SavaDx were both developed in-house. Both product candidates are substantially funded by peer-review research grant awards from the National Institutes of Health (NIH). Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimers disease, and related technologies, without royalty obligations to any third party.

About Cassava Sciences, Inc.Cassava Sciences mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimers disease. For more information, please visit: https://www.CassavaSciences.com

For More Information Contact:Eric Schoen, Chief Financial Officereschoen@CassavaSciences.com(512) 501-2450

Cassava Sciences open-label study of simufilam in Alzheimers disease is funded by clinical research grant #AG065152 from the National Institutes of Health (NIH/NIA).

The content of this press release is solely the responsibility of Cassava Sciences and does not necessarily represent the official views of the NIH/NIA.

Cassava Sciences Safe HarborThis news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: our strategy and plans; the treatment of Alzheimers disease; the status of current and future clinical studies with simufilam, including the interpretation of an interim analysis of open-label study results; planned enrollment and other changes to the open-label program; our intention to initiate a Phase 3 clinical program with simufilam in 2nd half 2021; results of our EOP2 meeting with FDA and the timing of further announcements; our ability to manufacture drug supply for a Phase 3 program and to enter into a long-term commercial drug supply agreement; the timing of validation studies with SavaDx; our ability to expand therapeutic indications for simufilam outside of Alzheimers disease; expected cash use in future periods; plans to publish results of a Phase 2b study in a peer-reviewed journal; verbal commentaries made by our employees; and potential benefits, if any, of the our product candidates. These statements may be identified by words such as may, anticipate, believe, could, expect, forecast, intend, plan, possible, potential, and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Our clinical results from earlier-stage clinical trials may not be indicative of full results or results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our business operations, and including those described in the section entitled Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2019 and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release.For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at http://www.sec.gov.

4, 5 Source: Alzheimers Association. Disease Facts and Figures. https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf

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Cassava Sciences Announces Significant Program Progress and Expected Key Milestones in 2021 for Its Clinical Program in Alzheimer's Disease -...

Roche refreshingly cautious on Alzheimer’s hopeful gantenerumab amid growing hype from rivals – FierceBiotech

Posted: at 6:55 pm


As Eli Lilly and Biogen stir up hope in the Alzheimers disease drug space, Roches pharma CEO is not getting dragged into hype over its effort gantenerumab.

Roche is certainly committed to gantenerumab, an antibody that binds to and clears aggregated beta amyloid fibers, despite it failing a phase 3 trial back in 2014. The Swiss pharma resurrected gantenerumab in 2017 and is now running two more phase 3 trials, although it was hit by another setback last year.

That came from a phase 2/3 study, sponsored by Washington University School of Medicine, with support from groups including Lilly and Roche. Investigators randomized 194 people with an early-onset, inherited form of Alzheimers to take either Lillys solanezumab, Roches gantenerumab or placebo and tracked them for up to seven years.

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Both of these anti-amyloid beta antibodies failed to improve outcomes, with the findings showing neither drug was effective in dominantly inherited Alzheimer's disease (DIAD). The primary endpoint tracked cognition annually for four years using four tests of early-stage disease, the results of which were combined to give a composite score.

Lilly has already seen enough data to say it has no plans to seek approval in the subpopulation of DIAD patients enrolled in the phase 2/3. Solanezumab has already failed in the broader Alzheimers population, leading Lilly to give up on the asset in 2016, but its still working through a study, A4, in people with amyloid buildup but no signs of cognitive impairment.

RELATED: Lilly hails Alzheimer's win with donanemab, boasting 'significant slowing of decline'

The Big Pharma did chalk up a small win last month, however, with a different asset: donanemab (once known as LY3002813), which works an active immunotherapy designed to stimulate a patients immune system to attack and destroy beta amyloid plaques that are believed to form in the brain and spur the memory-wasting disease.

Its antibody goes after a modified form of beta amyloid called N3pG, and targeting this produced in its midstage results a significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo.

It did not hit all of its secondaries and details were sparse, but shares still jumped on the news last month.

The drug that has come closest to backing up this amyloid idea is Biogens aducanumab, which binds to aggregated beta amyloid and causes it to be cleared from the body.

It had, in fact, been on the edge of being scrapped, but Biogen drilled down into the data and thought it saw a glimmer of hope, so it's gone to the FDA for approval. Its PDUFA was originally set for March, but an expert outside panel said it shouldn't be approved late last year.

Last month, the FDA said it was in fact delaying a decision on the med by as much as three months, until June 7. Usually, this is bad news, but Biogens shares jumped, presumably as a sign that it might be approved, as it wasnt an outright rejection.

Despite the roller coaster ride in Alzheimer's over the years, and Roches own failure in DIAD patients, the Swiss major last year talked up the differences between the phase 2/3 flop and its ongoing late-phase studies to explain its continued confidence that gantenerumab may succeed.

Outside observers took a different position. Analysts at Jefferies expected the phase 2/3 trial to fail and accepted that the small size of the study and initial use of potentially suboptimal doses may have contributed to the lackluster data. Even so, the analysts said the failure again suggests the ongoing gantenerumab phase 3 studies are high risk.

Roche is set to find out whether that risk has paid off when it posts data from the phase 3 program in 2022. The program is assessing whether increasing the gantenerumab dose above the level used in earlier, failed trials will lead to better outcomes.

Given the talking up of Alzheimers prospects once again in the face of the glimmers from Biogen and Lilly, analysts on Roches financial call Thursday were quick to ask about how the C-suite viewed the future of gantenerumab, and that ongoing test.

RELATED: Biogen bullish on Alzheimer's drug approval, sees Lilly data as positive despite AdComm rejection

For once, the answer was measured (and very different from highly bullish Biogen at the J.P. Morgan healthcare conference last month, which also pointed to Lillys data as more hope for its once-failed candidate).

Well, believe me, it's on all of our minds, said Roches pharma chief Bill Anderson of the drug. We have lots of reasons to believe, and we have reasons to be concerned. Until there's a definitive, unassailable, pivotal result or pair of pivotal results, I think we have to handicap all these studies. And that's just how it is when you're pioneering in a new area. So, I can give you the five reasons we're excited. And then I would still say, I don't know.

He said, on reflection, success is likely a tossup. This is a difficult, difficult disease, he said. We don't understand the pathophysiology of Alzheimer's disease, and we're targeting something that is in a huge evidence that it's linked to Alzheimer's, but the causative role that it plays, we don't know. And the data that came out from another company (Eli Lilly), they did last quarter, people got really excited about, and I want to be excited to. But again, that's a little bit of a slight tweak on the MoA. It's a novel endpoint. It's a small data set. And we haven't seen the data yet. So I'm not going to take that and run off to celebrate.

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Roche refreshingly cautious on Alzheimer's hopeful gantenerumab amid growing hype from rivals - FierceBiotech

Ben-Gurion University Researchers Introduce New Method for Diagnosing Neurological and Psychiatric Conditions – PRNewswire

Posted: at 6:55 pm


BEER-SHEVA, Israel, Feb. 9, 2021 /PRNewswire/ -- Researchers at Ben-Gurion Universityof the Negev (BGU) have developed a new method for rapidly diagnosing brain blood vessel pathology that may lead to neurodegenerative diseases, such as Alzheimer's disease, as well as other neurological and psychiatric conditions, including epilepsy, traumatic brain injury and stroke. The novel method is based on analysis of EEG patterns using proprietary algorithms and was invented by Dr. Dan Milikovsky and Prof. Alon Friedman, MD-PhD, Departments of Physiology and Cell Biology, Cognitive and Brain Sciences, Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev.

The novel diagnostic method is based on findings from the lab of Prof. Friedman that patients with Alzheimer's disease and other brain conditions display nonconvulsive epileptic seizure-like activity that can be detected by EEG recordings. The study was published in the highly ranked Science Translational Medicine Journal [i]. This abnormal activity reflects pathological changes in dysfunction of the brain blood vessels, which contribute, according to recent studies, to the pathogenesis of various neurodegenerative and other neuro-psychiatric disorders.

"Research from our lab and others, shows that the pathological changes in the brain blood vessels, which are usually referred to as the blood-brain barrier (BBB), contribute to the formation of Alzheimer's disease and other brain disorders. Since dysfunction of the BBB is also a key component in the pathogenesis of epilepsy, we hypothesized that BBB dysfunction in Alzheimer's patients would also trigger abnormal brain activity that could be detected by EEG, an accessible and affordable tool used in the clinic, and serve as a diagnostic method for these conditions," explained Prof. Friedman. "Indeed, we find abnormal, epileptic-like EEG recordings in many patients with Alzheimer's disease as well as epilepsy, which reflect brain blood vessel pathology and can serve both for diagnosis as well as a therapeutic target."

The technology was successfully tested on animal models and dozens of patients and is now been validated on large databases of EEG records of thousands of patients.

"This new approach for diagnosing neurological conditions based on analysis of changes of blood vessels in the brain can be valuable for the early detection of Alzheimer's disease and other neurological conditions, at the stage when treatment can still slow down disease progression. The technology offers a biomarker for immediate results and allows for the continuous monitoring of the progression of the neurological condition and response to treatment," said Josh Peleg, CEO of BGN Technologies. "We are now seeking a potential industry partner for the further development of this promising method for a variety of applications, from monitoring of ICU patients, to patients after stroke and head injuries and for the diagnosis of vascular pathology in early Alzheimer's disease."

About BGN Technologies

BGN Technologiesis the technology transfer companyof Ben-Gurion University, the third largest university in Israel. BGN Technologies brings technological innovations from the lab to the market and fosters research collaborations and entrepreneurship among researchersand students. To date, BGNTechnologieshas established over 100 startup companiesin the fields of biotech, hi-tech, and cleantech, and has initiated leading technology hubs,incubators, and accelerators.Over the past decade, BGN Technologies has focused on creating long-term partnerships with multinational corporations such as Deutsche Telekom, Dell-EMC, PayPal, and Lockheed Martin, securing value and growth for Ben-Gurion University as well as the Negev region.For more information, visit the BGN Technologies website.

[i] Milikovsky1 et al. (Dec. 2019), Paroxysmal slow cortical activity in Alzheimer's disease and epilepsy is associated with blood-brain barrier dysfunction. Science Translational Medicine: Vol. 11, Issue 521, eaaw8954.

Media Contact:Tsipi HaitovskyGlobal Media LiaisonBGN TechnologiesTel: +972-52-598-9892E-mail: [emailprotected]

SOURCE BGN Technologies

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Ben-Gurion University Researchers Introduce New Method for Diagnosing Neurological and Psychiatric Conditions - PRNewswire

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