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Researchers return to Alzheimer's vaccines, buoyed by recent drug success

CHICAGO, Nov 20 (Reuters) - Breakthrough Alzheimer’s treatments that remove toxic proteins from the brain have revived interest in vaccines to treat the memory-robbing disease, potentially offering a cheaper, easy-to-administer option for millions of people, according to interviews with 10 scientists and company executives.

Clinical trials are underway or completed for at least seven Alzheimer’s vaccines designed to harness the immune system to rid the brain of the disease-related proteins beta-amyloid or tau, a review of the U.S. government’s ClinicalTrials.gov database found. More are on the way.

The renewed interest in Alzheimer's vaccines follows a promising first attempt more than 20 years ago that was abandoned after 6% of study volunteers developed life-threatening brain inflammation known as meningoencephalitis.

Researchers then pivoted to a safer route, infusing highly targeted man-made antibodies into patients that sidestep the body’s immune machinery.

Eisai (4523.T) and Biogen's (BIIB.O) newly launched Leqembi and Eli Lilly's (LLY.N) donanemab, now under U.S. regulatory review, are two such treatments that cemented the view that removing amyloid is key to fighting Alzheimer’s in people with early-stage disease. That success followed years of failures that left many experts questioning the amyloid theory.

Read more - https://www.reuters.com/business/healthcare-pharmaceuticals/researchers-return-alzheimers-vaccines-buoyed-by-recent-drug-success-2023-11-20/


Antidepressants Don’t Work the Way Many People Think

November 8, 2023 (NY Times) Over the course of the Covid-19 pandemic, rates of depression and anxiety soared, and many Americans turned to antidepressant medication to help them cope. Even before the emergence of Covid, 1 in 8 American adults was taking an antidepressant drug. According to one estimate, that number rose by 18.6 percent during 2020. Zoloft is now the 12th most commonly prescribed medication in the United States.

Given this, you might assume that the question of how — and how well — these drugs work has been clearly answered. And yet recent papers have challenged their efficacy and actions in the brain. Some researchers even say the medications are barely better than a placebo and ask whether they warrant such widespread use.

For psychiatrists, this debate is nothing new. Dr. David Hellerstein, a professor of clinical psychiatry at the Columbia University Irving Medical Center, said the question comes in many iterations but boils down to: Do antidepressants work?

Read the full article here - https://www.nytimes.com/2022/11/08/well/mind/antidepressants-effects-alternatives.html?smid=nytcore-ios-share&referringSource=articleShare


Enhanced Natural Killer Cell Therapy Shows Promise in Alzheimer's

November 2, 2023 (Medscape) An investigational natural killer cell (NK) therapy has shown promise in the treatment of Alzheimer's disease (AD), in a small phase 1 proof-of-concept clinical trial.

SNK01, being developed by NKGen Biotech, is an autologous, nongenetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression.

"When we give these enhanced natural killer cells intravenously, not only do they get into the brain, but we've shown, through CSF biomarker data, that they reduce both amyloid and tau proteins, dramatically reducing the neuroinflammation," Paul Song, MD, chief executive officer of NKGen Biotech, told Medscape Medical News.

"Remarkably," in the first 6 months, 90% of patients with AD demonstrated improvement or maintained stable cognitive function, based on the AD Composite Score (ADCOMS), suggesting that SNK01 may do more than simply slow disease progression, Song said.

The findings were presented at the 16th Clinical Trials on Alzheimer's Disease (CTAD) conference.

Read the full article here - https://www.medscape.com/viewarticle/998022


NYTimes: How to Know if You Have a Genetic Risk for Alzheimer’s

The actor Chris Hemsworth announced last week that he’s taking a break from acting to focus on his health. The news came after Mr. Hemsworth learned through genetic testing that he has two copies of the APOE4 gene variant, which is associated with increased odds of developing Alzheimer’s disease, the most common form of dementia. The 39-year-old star of “Thor” has not reported having any symptoms, but he told Vanity Fair that he wanted to focus on mitigating his risk as much as possible.

Should you, like Mr. Hemsworth, undergo genetic testing to assess your risk for Alzheimer’s? And if you have the variant, what options are available to prevent or delay the condition? Here’s what to know.


Enhanced Natural Killer Cell Therapy Shows Promise in Alzheimer's

November 2, 2023 (Medscape) An investigational natural killer cell (NK) therapy has shown promise in the treatment of Alzheimer's disease (AD), in a small phase 1 proof-of-concept clinical trial.

SNK01, being developed by NKGen Biotech, is an autologous, nongenetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression.

"When we give these enhanced natural killer cells intravenously, not only do they get into the brain, but we've shown, through CSF biomarker data, that they reduce both amyloid and tau proteins, dramatically reducing the neuroinflammation," Paul Song, MD, chief executive officer of NKGen Biotech, told Medscape Medical News.

Read more - https://www.medscape.com/viewarticle/998022?&icd=login_success_email_match_fpf


First-in-Class Regenerative Therapeutic for Alzheimer's Promising

October 30, 2023 (Medscape) Allopregnanolone, a first-in-class regenerative therapeutic, has the potential to delay neurodegeneration in early Alzheimer's disease (AD) by promoting endogenous systems of renewal and repair, early clinical data show.

In a small phase 1b/2a study, the drug was safe and well-tolerated and increases in hippocampal volume and beneficial structural and functional brain changes were noted with once-weekly treatment.

In presenting the findings at the 16th Clinical Trials on Alzheimer's Disease (CTAD) conference, study investigator Roberta Brinton, PhD, with The Center for Innovation in Brain Science at the University of Arizona in Tucson, gave a "whirlwind tour of decades of research" into allopregnanolone — "from discovery to translation to now in clinical trials."

She explained that allopregnanolone is a pleiotropic neuro-steroid that promotes neurogenesis, oligogenesis, and synaptogenesis, as well as mitochondrial function and has anti-inflammatory effects. It also promotes cholesterol efflux, which then leads to a reduction in beta-amyloid generation.

Read the full article - https://www.medscape.com/viewarticle/997873?form=fpf


October 16, 2023 (New York Times) In some patients, remnants of the coronavirus in the gut may stifle the production of serotonin, an important neurotransmitter, researchers suggest.

A team of scientists is proposing a new explanation for some cases of long Covid, based on their findings that serotonin levels were lower in people with the complex condition.

In their study, published on Monday in the journal Cell, researchers at the University of Pennsylvania suggest that serotonin reduction is triggered by remnants of the virus lingering in the gut. Depleted serotonin could especially explain memory problems and some neurological and cognitive symptoms of long Covid, they say.

This is one of several new studies documenting distinct biological changes in the bodies of people with long Covid — offering important discoveries for a condition that takes many forms and often does not register on standard diagnostic tools like X-rays.

The research could point the way toward possible treatments, including medications that boost serotonin. And the authors said the biological pathway that their research outlines could unite many of the major theories of what causes long Covid: lingering remnants of the virus, inflammation, increased blood clotting and dysfunction of the autonomic nervous system.

Read the full article - https://www.nytimes.com/2023/10/16/health/long-covid-serotonin.html?smid=nytcore-ios-share&referringSource=articleShare


August 29 - The price negotiation program, established by Democrats as part of the Inflation Reduction Act, is projected to save the government tens of billions of dollars in the coming years.

The medications — which treat diabetes, cancer and other conditions — are taken by millions of older Americans and cost Medicare billions of dollars annually. The Centers for Medicare & Medicaid Services selected the drugs through a process that prioritized ones that account for the highest Medicare spending, have been on the market for years and do not yet face competition from rivals. Additional medications will be selected for price negotiations in the coming years.

Read more - https://www.nytimes.com/2023/08/29/us/politics/medicare-drug-pricing-negotiations.html?smid=nytcore-ios-share&referringSource=articleShare


Eris, BA.2.86: Do I need to worry about COVID again?

Aug 19 (Reuters) - The World Health Organization and the U.S. Centers for Disease Control and Prevention are tracking a new, highly mutated lineage of the virus that causes COVID-19.

Six cases in four countries have been detected since late July. Scientists are keeping an eye on the new lineage, named BA.2.86, because it has 36 mutations that distinguish it from the currently-dominant XBB.1.5 variant.

So far there is no evidence that BA.2.86 spreads faster or causes more serious illness than previous versions. The CDC said its advice on protecting yourself from COVID remains the same.

Read more - https://www.reuters.com/business/healthcare-pharmaceuticals/eris-ba286-do-i-need-worry-about-covid-again-2023-08-19/


EG.5 is spreading quickly, but experts say it’s no more dangerous than previous versions.

Concern is rising about the Covid-19 variant EG.5. This week, it became the dominant variant in the United States, and the World Health Organization classified EG.5 as a “variant of interest,” meaning it has genetic changes that give it an advantage and its prevalence is growing. So how worried should people be about it?

While severe illness in older adults and people with underlying conditions is always a concern, as is long Covid in anyone who gets infected, experts say EG.5 does not pose a substantial threat — or at least no more of one than any of the other major variants currently circulating.

Read more - https://www.nytimes.com/2023/08/11/well/live/covid-variant-eris-eg5.html?smid=nytcore-ios-share&referringSource=articleShare

 


Long-term use of certain reflux medications is associated with a higher risk of dementia, study suggests

CNN —
Millions of Americans take medications known as proton pump inhibitors every day to treat heartburn and acid reflux, and in recent years, these drugs, also known as PPIs, have been linked to a greater risk of kidney failure, stroke, and early death from any cause.
And new research suggests that there may also be a higher risk of dementia for people who take the medications over several years.
People 45 and up who took PPIs for over four years had a 33% higher risk of developing dementia than people who never took the drugs, according to a study published Wednesday in the journal Neurology.

Read more - https://www.cnn.com/2023/08/09/health/acid-reflux-medication-dementia/index.html


Promising new Alzheimer's drugs may benefit whites more than Blacks

NEW YORK, July 31 (Reuters) - Groundbreaking treatments for Alzheimer's disease that work by removing a toxic protein called beta amyloid from the brain may benefit whites more than Black Americans, whose disease may be driven by other factors, leading Alzheimer's experts told Reuters.

The two drugs – Leqembi, from partner biotech firms Eisai (4523.T) and Biogen (BIIB.O), and an experimental treatment developed by Eli Lilly (LLY.N), donanemab - are the first to offer real hope of slowing the fatal disease for the 6.5 million Americans living with Alzheimer's.

Read more - https://www.reuters.com/business/healthcare-pharmaceuticals/promising-new-alzheimers-drugs-may-benefit-whites-more-than-blacks-2023-07-31/?fbclid=IwAR3Xzt7KeZ3Yz5PqhD2Q9GSTtQGySIXDG6vCyBHj5cIGhFErYx0Mf03MYL4


Biden-Harris Administration Announces Medicare Dementia Care Model

Jul 31, 2023
New Model Enhances Care Coordination and Increases Support for Caregivers

The Biden-Harris Administration is taking further action on its commitment to promote care and support for people with Medicare living with dementia and their unpaid caregivers. Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced its Guiding an Improved Dementia Experience (GUIDE) Model, which aims to improve the quality of life for people living with dementia, reduce strain on unpaid caregivers, and help people remain in their homes and communities through a package of care coordination and management, caregiver education and support, and respite services. The GUIDE Model will be tested by the Center for Medicare and Medicaid Innovation and is a key deliverable from President Biden’s April 2023 Executive Order on Increasing Access to High-Quality Care and Supporting Caregivers, as well as key goals of the National Plan to Address Alzheimer’s Disease (National Plan).

“HHS continues to innovate to help Americans living with dementia and their unpaid caregivers. Our new GUIDE Model has the potential to improve the quality of life for people with dementia and alleviate the significant strain on our families,” said HHS Secretary Xavier Becerra. “We are proud to take these steps to deliver on the President’s promise to increase care coordination and improve access to services and supports for our families.”

Read more - https://www.cms.gov/newsroom/press-releases/biden-harris-administration-announces-medicare-dementia-care-model


On July 31, 2023, the Centers for Medicare & Medicaid Services (CMS) announced a new voluntary nationwide model – the Guiding an Improved Dementia Experience (GUIDE) Model – a model test that aims to support people living with dementia and their unpaid caregivers. CMS is accepting letters of interest for the GUIDE Model through September 15, 2023, and will release a GUIDE Request for Applications (RFA) for the model in Fall 2023. The model will launch on July 1, 2024, and run for eight years.

Model Overview

The GUIDE Model will focus on dementia care management and aims to improve quality of life for people living with dementia, reduce strain on their unpaid caregivers, and enable people living with dementia to remain in their homes and communities. It will achieve these goals through a comprehensive package of care coordination and care management, caregiver education and support, and respite services.

GUIDE delivers on the Biden Administration’s April 2023 Executive Order 14095 on Increasing Access to High-Quality Care and Supporting Caregivers, which directed the Secretary of Health and Human Services to “consider whether to select for testing by the Center for Medicare and Medicaid Innovation an innovative new health care payment and service delivery model focused on dementia care that would include family caregiver supports such as respite care.”

It also advances key goals of the National Plan to Address Alzheimer’s Disease, which was established through the bipartisan National Alzheimer’s Project Act (NAPA) and has, for over a decade, accelerated federal actions to optimize the quality of care for people living with dementia and their caregivers while advancing research towards a cure. The GUIDE Model builds off of this extensive coordination within HHS and major input from various external stakeholders.

Read more - https://innovation.cms.gov/innovation-models/guide


 

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