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ausetkmt · 3 months

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New Alzheimer's drugs bring hope. But not equally for all patients.

https://www.washingtonpost.com/health/2024/01/29/alzheimers-new-drugs-black-patients-leqembi/

ABINGTON, Pa. — Wrapped in a purple blanket, Robert Williford settles into a quiet corner of a bustling neurology clinic, an IV line delivering a colorless liquid into his left arm.

The 67-year-old, who has early Alzheimer’s disease, is getting his initial dose of Leqembi. The drug is the first to clearly slow the fatal neurodegenerative ailment that afflicts 6.7 million older Americans, though the benefits may be modest. The retired social worker, one of the first African Americans to receive the treatment, hopes it will ease his forgetfulness so “I drive my wife less crazy.”

But as Williford and his doctors embark on this treatment, they are doing so with scant scientific data about how the medication might work in people of color. In the pivotal clinical trial for the drug, Black patients globallyaccounted for only 47 of the 1,795 participants — about 2.6 percent. For U.S. trial sites, the percentage was 4.5 percent.

The proportion of Black enrollees was similarly low for Eli Lilly Alzheimer’sdrug, called donanemab, expected to be cleared by the Food and Drug Administration in coming months. Black people make up more than 13 percent of the U.S. population.

The paltry data for the new class of groundbreaking drugs, which strip a sticky substance called amyloid beta from the brain, has ignited an intense debate among researchers and clinicians. Will the medications — the first glimmer of hope after years of failure — be as beneficial for African Americans as for White patients?

“Are these drugs going to work in non-Whites? And particularly in Blacks? We just don’t have enough data, I don’t think,” said Suzanne E. Schindler, a clinical neurologist and dementia specialist at Washington University in St. Louis. “In general, the default is that they will work the same in everybody, but we don’t really know that for sure.”

The situation casts a spotlight yet again on the decades-long failure of researchers to reflect the increasingly diverse character of the patient population in the United States, and underscores the stark disparities in Alzheimer’s treatment and care. Black Americans develop the disease and related dementias at twice the rate of their White counterparts, but are less likely to receive specialized care and are diagnosed at later stages, studies show. That’s an urgent problem considering that the new drugs must be used early to have an effect.

In addition, a perplexing new issue appears to be contributing to low Black enrollment in trials and is fueling a debate among experts about the role of race, genetics and other factors. To qualify for the main trial for Leqembi — developed by the Japanese pharmaceutical giant Eisai and the biotechnology company Biogen of Cambridge, Mass. — participants were required to have elevated levels of brain amyloid, a defining characteristic of Alzheimer’s, and symptoms such as memory loss.

But brain scans showed that the African American volunteers were less likely to have excess amyloid than White patients and thus were excluded from the trial at higher rates. Almost half of Black applicants failed to meet the amyloid threshold, compared with 22 percent of White volunteers, according to Eisai. A similar pattern occurred with the Lilly drug and in some other studies, and sometimes involved other people of color, including Hispanics.

Experts are baffled by the findings. Why would amyloid levels — thought to be a key driver of Alzheimer’s — be different in people with similar cognitive problems?

“Is it the color of someone’s skin? Almost certainly not,” said Joshua D. Grill, an Alzheimer’s researcher at the University of California at Irvine. “Is it a difference in genetics? Or other health conditions, like cholesterol, blood pressure or vascular health? Or is it something else, that we haven’t measured?”

While the biology of Alzheimer’s is almost surely the same regardless of race, some researchers say the patients themselves might be different because of underlying health conditions. Some older Black patients diagnosed with Alzheimer’s, they say, might actually have vascular dementia stemming from heart disease, hypertension and diabetes — all conditions more prevalent among African American patients.

The risk of vascular damage also could be increased by a lack of access to health care and years of exposure to racism, as well as genetics, some experts say. And many patients could have a constellation of pathologies driven by other factors, they add.

Whatever the cause, experts say, the bottom line is the same: Patients who do not have excessive amounts of the sticky brain protein should not be treated with the amyloid-targeting drugs because the therapies are unlikely to work and pose substantial risks, including potentially deadly bleeding in the brain.

But that raises the specter of another disparity. If it turns out that a lower proportion of Black dementia patients and other people of color have excess amyloid, they could be left behind as the drug industry races to develop amyloid-reducing treatments. To counter that, experts are urging companies to accelerate work addressingother potential drivers of cognitive decline and to develop combination drugs with multiple targets.

“If we are just targeting amyloid, we can just miss a large potential population that might benefit from treatment,” said Lisa L. Barnes, a neuropsychologist at Rush University in Chicago.

‘A brain is a brain’

For now, the question remains: What should Black patients and their doctors think about the anti-amyloid drugs?

The answer, experts say, depends largely on the level of amyloid in their brains.

More than a year ago, Williford was diagnosed with early Alzheimer’s by David C. Weisman, a neurologist at Abington Neurological Associates, a large practice north of Philadelphia that treats patients and conducts clinical trials for drug companies. The clinic was one of the test sites for Leqembi.

After Leqembi receivedfull FDA approval last summer, Williford underwent tests to determine whether he was a good candidate for the drug. One test — a lumbar puncture, sometimes called a spinal tap — showed elevated amyloid in his brain. That means Williford and similar patients are likely to benefit from an anti-amyloid medication regardless of their race or ethnicity, Weisman and several other experts said.

“A brain is a brain is a brain, whether it is Asian, Hispanic, African American or White,” Weisman said. “A patient is either a good fit or a bad fit, and Robert is a good fit.”

Williford, who spent years working with troubled families in Philadelphia, began having memory problems a few years ago, said his wife, Cynthia Byron-Williford, 59.

“You could tell him almost anything, and he would almost immediately forget,” she said. “If I asked him to make a peanut butter sandwich for our grandson, he would come back three times and say, ‘What am I supposed to do?’”

With few treatment options, many physicians say they will offer anti-amyloid therapy to any patient who has elevated levels of the substance and passes safety tests.

Barry W. Rovner, a neurology professor at Thomas Jefferson University in Philadelphia, said he would not hesitate to offer Leqembi to African American patients who tested positive for amyloid. But, he added, because of the low numbers of Black individuals in the Leqembi trial, “I would say, ‘Look, this has not been tried in many Black people, so we don’t know precisely how it is going to work. But you don’t know precisely how it will work in any person.’”

From a research perspective, “You could say, as a group we don’t know if Black individuals respond the same way to anti-amyloid drugs because we don’t have the data,” Washington University’s Schindler said. “But on an individual level, it is different. If I had a Black patient who was amyloid-positive, I would start him on these drugs.”

But some Black patients might not be comfortable with the medication.

Zaldy S. Tan, director of the memory disorders center at Cedars-Sinai Medical Center in Los Angeles, said when African American patients are informed about the risks and benefits of Leqembi, and about the sparse data available for Black individuals, some will “take a pause and question whether they are willing to accept the uncertainty” and challenges of receiving the every-other-week infusion and multiple follow-up tests.

A promise of diversity

The best way to know for sure how drugs for Alzheimer’s — and other diseases — affect different populations is to have more diversity in trials, experts agree. But research participation by Black Americans and other people of color has been held down for years for several reasons.

The 20th century’s infamous Tuskegee syphilis study created long-standing mistrust about trials within the African American community. Men were left untreated to suffer and die even after an effective treatment emerged for the bacterium.

Alzheimer’s research, meanwhile, has long been centered in memory clinics at elite academic institutions, which tend to attract well-heeled patients with health insurance and other resources. The clinics have served as effective recruiting grounds for trials that end up with a predominantly White enrollment.

“We have done a poor job of making African American Alzheimer’s research inclusive,” said John Morris, a neurologist at Washington University in St. Louis. More than two decades ago, he created an African American advisory board at the school’s Knight Alzheimer Disease Research Center after realizing only 3 percent of trial participants were Black.

Others also are redoubling efforts to increase diversity. John Dwyer, president of the Global Alzheimer’s Platform Foundation, a nonprofit that runs trials, said the organization has sharply increased participation by people of color by sending dedicated teams of African American and Latino professionals into communities to build relationships with physicians and personnel at health centers, senior centers and places of worship. They stress to the communities how much they can benefit from the studies, he said.

Stephanie Monroe, vice president and senior adviser of health equity and access at the advocacy group UsAgainstAlzheimer’s, noted that low Black enrollment is not limited to Alzheimer’s trials. If all the drugs that have not been tested on people of color were eliminated, the shelves of pharmacies would be nearly empty, she said.

“That doesn’t work when you are almost a 50-50 minority/majority population,” Monroe said.

The FDA has issued guidelines for industry designed to bolster diversity in studies, while the National Institute on Aging recently pledged toprioritize funding requests that are “appropriately inclusive.”

The low Black enrollment in studies is just the latest controversy involving the anti-amyloid drugs. For years, earlier versions of the drugs failed repeatedly in trials. By contrast, Leqembi, in an 18-month trial, showed unambiguous, if modest, benefits, slowing disease progression by about 27 percent, or roughlyfive months. The drug, administered every other week, carries a list price of $26,500 a year.

In July, Lilly reported that its anti-amyloid drug, donanemab, was even more effective at removing amyloid. But like Leqembi, it can cause serious side effects, including brain hemorrhages. Some doctors think the drugs will provide bigger benefits when taken for a longer period or earlier in the disease, but others say the medications, which require repeated MRIs to check for side effects, leave much to be desired.

Both Eisai and Lilly said they are working hard to increase diversity in clinical trials. In the meantime, they said, patients with elevated amyloid should benefit from the anti-amyloid drugs, regardless of race or ethnicity.

“We have no pathophysiological reason to expect different efficacy between races and ethnicities for Alzheimer’s treatments that remove amyloid,”Lillysaid in a statement.

Eisai acknowledged that the Leqembi trial was not designed to test the drug in individual racial and ethnic subgroups. But it said in a statement that the totality of the evidence indicated that “all patients, regardless of ethnicity, benefited from treatment” with the drug.

“We and the U.S. FDA — as evidenced by the agency’s approval of Leqembi — believe that the benefits and risks in these patient populations and races has been established,” the company added. Eisai said volunteers who did not pass the amyloid threshold did not have Alzheimer’s and should be assessed for other conditions.

In an interview, Teresa Buracchio, acting director of the FDA’s Office of Neuroscience, said the agency “did not see a notable difference by race” in safety and effectiveness in the limited data available on subgroups in the Leqembi trial.

But other experts were skeptical, saying the number of Black patients in the Leqembi trial was too low to know whether the medication is safe and effective for African Americans. “Without having a representative population, it is impossible to assess,” said Barnes, of Rush University.Some researchers suggested that patients in underrepresented populations should wait for future advances in treatment.

‘We just want to get going’

On a recent day, nurse Christine Besso bustled in and out of Williford’s infusion room at the neurology clinic, taking his vital signs and inserting an IV line. “Let’s get this party started,” she said.

Byron-Williford, watching the process from a nearby couch, said she was not concerned about the low numbers of African Americans in the Leqembi trial.

“I think it will work or not work based on the individual,” she said, adding with a laugh, “and if it doesn’t work for him, it is because he is ornery.”

Byron-Williford said her husband’s health problems accelerated a few years ago after his son, who was in his early 20s, died unexpectedly. Williford became depressed and lost his appetite. Last summer, when he went to pick up his wife at a nearby hair salon, he drove around, lost. She later confiscated his car keys.

In the clinic, shortly after Williford’s infusion began, Weisman stopped in to check on him and discuss possible side effects. When Williford asked him how long he would be on the drug, Weisman shrugged, saying it depended on how he did on the drug and on test results.

“We are getting on an airplane, and we don’t even have a destination airport yet,” Weisman said. “We just want to get going.”

#Black Lives Matter #Alzheimers #Dementia #Black Lives #Black Health Matters #Black Medical Professionals #New Alzheimer’s drugs bring hope But not equally for all patients.#Mental Health Care

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vanx-97 · 7 months

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When did you stop being yourself?

Do I know you? I can't tell

Sometimes you are familiar

Other times you are someone else

#mental health #mental illness #drugs #lean #music #new rapper #poems and poetry #poetry #poet #dark poetry #alzheimers #dementia #bipolar disorder #depression #anxiety #fear #sadness #dark thoughts

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decompose1 · 1 year

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what if i took a bunch of dxm and listened to all of Everywhere at the End of Time. that sounds like a really good idea

#alzheimer's speedrun #rabbit.txt #drugs cw

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quotesfrommyreading · 1 year

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For decades, nursing homes have been using drugs to control dementia patients. For nearly as long, there have been calls for reform.

In 1987, President Ronald Reagan signed a law banning the use of drugs that serve the interest of the nursing home or its staff, not the patient.

But the practice persisted. In the early 2000s, studies found that antipsychotic drugs like Seroquel, Zyprexa and Abilify made older people drowsy and more likely to fall. The drugs were also linked to heart problems in people with dementia. More than a dozen clinical trials concluded that the drugs nearly doubled the risk of death for older dementia patients.

In 2005, the Food and Drug Administration required manufacturers to put a label on the drugs warning that they increased the risk of death for patients with dementia.

Seven years later, with antipsychotics still widely used, nursing homes were required to report to Medicare how many residents were getting the drugs. That data is posted online and becomes part of a facility’s “quality of resident care” score, one of three major categories that contribute to a home’s star rating.

The only catch: Antipsychotic prescriptions for residents with any of three uncommon conditions — schizophrenia, Tourette’s syndrome and Huntington’s disease — would not be included in a facility’s public tally. The theory was that since the drugs were approved to treat patients with those conditions, nursing homes shouldn’t be penalized.

The loophole was opened. Since 2012, the share of residents classified as having schizophrenia has gone up to 11 percent from less than 7 percent, records show.

The diagnoses rose even as nursing homes reported a decline in behaviors associated with the disorder. The number of residents experiencing delusions, for example, fell to 4 percent from 6 percent.

— Phony Diagnoses Hide High Rates of Drugging at Nursing Homes

#katie thomas #robert gebeloff #jessica silver-greenberg #phony diagnoses hide high rates of drugging at nursing homes #current events #history #medical history #caretaking #elder care #elder neglect #healthcare #medicine #dementia #alzheimer's disease #nursing #ronald reagan #quetiapine #olanzapine #aripiprazole

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angelnumber27 · 1 year

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s moke some heroin

no dumbass I’m off opiates and have been for a loooong time lol 🫶🏻🖕🏻

#who smokes heroin #lmfao #tw stupidity #drugs mention #heroin mention #h mention #Don’t do that that tinfoil Alzheimer’s ass shit

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substition · 1 year

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#health #alzheimer's #science #neuroscience #drugs

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abysswatchers420 · 1 day

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how can you say some kid had such a bright future ahead of him when he CHOSE to go out and use heroin? ?? the fuck does That say?

#out here thinking 'a little heroin never hurt anybody' thats the fucking drug i was gonna use to kill myself if/when i get alzheimers #what a dumbass. you made ur bed now ur lying in it. gg

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edsonjnovaes · 9 days

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Alzheimer, uma doença autoimune 1.2

O psiquiatra alemão Alois Alzheimer descreveu o primeiro caso do estado que leva seu nome em 1906. Mais de um século depois, a comunidade científica ainda não compreende os mecanismos exatos. Manuel Ansede – El País. O Globo – 06/03/2024 in: Jesus Hemp – 2024 abr 15 haydenbird – Getty Images Em um artigo publicado numa terça-feira (20/09/2022), o professor de química Donald Weaver, diretor do…

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#Alzheimer pode ser uma doença autoimune # amiloide # Anvisa EUA # Augusto Dala Costa - terra # Bethânia Nunes - Metrópoles # biólogo belga Bart De Strooper principais especialistas mundiais Alzheimer # Centro para a Pesquisa do Cérebro e suas Doenças em Lovaina # cidade belga de Tielt 64 anos # Cientistas da Universidade de Toronto # consórcio internacional # dados falsificados # distúrbio do sistema imunológico # doença autoimune cérebro # e não uma condição cerebral # Food and Drug Administration FDA # haydenbird/GettyImages # Manuel Ansede - El País. O Globo # organização sem fins lucrativos Alzheimer’s Disease International # portal Science Alert # previsão reveladora humanidade # principal estudo sobre a beta-amiloide 2006 # professor de química Donald Weaver diretor do laboratório Krembil Research Institute University Health Network Canadá # psiquiatra alemão Alois Alzheimer # SaúdeTags # tratamento da doença de Alzheimer #fake news #Medicinal

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pressnewsagencyllc · 26 days

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American pharma major Eli Lilly's big focus on India: Will the company's strategy work?

So, you drive to the local park for your morning walk, drive and take a Metro to your office, where you grab the lift to the third floor, and then you repeat the commute in the evening. If you have to queue up for an autorickshaw, you crib about last-mile connectivity to your doorstep, instead of walking that mile. That’s rising urbanisation and sedentary lifestyles for you. The bane of modern…

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marketsresearchinsights · 2 months

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Alzheimer’s Drugs Market Opportunities, Trends, and Forecasts by 2030

The Insight Partners is excited to announce the release of groundbreaking findings in its latest market research report, "Overview of Alzheimer?s Drugs Market Share, Size, and Forecast | 2030". The panoramic research, conducted by our team of seasoned experts, provides valuable insights on the Alzheimer?s Drugs market forecast, key trends, drivers, challenges, and opportunities within the Alzheimer?s Drugs market.

The report unveils a detailed Alzheimer?s Drugs market analysis of the current Alzheimer?s Drugs market size and projects future growth trends based on historical data and market dynamics. At our research firm, we aim to help investors by providing both qualitative and quantitative data through this study. This global Alzheimer?s Drugs market report, competitive landscape, risks and barriers to entry for market players, sales channels, distributors, and Porter's Five Forces Analysis.

Businesses must have a firm understanding of the market, before making significant investments. It makes financial sense to allocate a modest portion of your company's expenditure to reliable market research. With a team of well-versed experts, we deliver actionable insights and strategic intelligence to help businesses navigate the complexities of the market landscape. Our commitment to excellence and innovation sets us apart as a trusted partner for organizations seeking a competitive edge.

Why Opt for Our Alzheimer?s Drugs Market Research Report?

Our researchers employ a multi-faceted approach to data collection, utilizing primary and secondary sources to ensure the breadth and depth of information.

Our researchers analyze consumer behavior, market trends, and brand positioning methods. Every piece of data undergoes a rigorous validation process to ensure accuracy and reliability.

We prioritize clarity and conciseness in our reporting, presenting findings in a format that is easily digestible for our clients.

We develop customized analytical models tailored to the specific nuances of the Alzheimer?s Drugs market, allowing us to uncover hidden patterns and trends.

The report answers the following questions:

What are the primary factors driving the Alzheimer?s Drugs market growth during the projected period?

What region is likely to witness the most substantial growth?

Which Alzheimer?s Drugs market trend will take center stage in the coming years?

What are the key challenges hindering the Alzheimer?s Drugs market expansion?

Emerging Trends: Our report uncovers emerging trends that are poised to reshape the Alzheimer?s Drugs market equipping businesses with the foresight to stay ahead of the competition.

Competitive Landscape: The Insight Partners explores the competitive landscape, offering insights into key Alzheimer?s Drugs market players, their strategies, and potential areas for differentiation. The key companies in the Alzheimer?s Drugs market are Pfizer Inc., Siemens Healthcare GmbH, Teva Pharmaceutical Industries Ltd., GlaxoSmithKline plc, Sanofi, Novartis AG, AstraZeneca, AbbVie Inc., Eisai Co., Ltd., Takeda Pharmaceutical Company Limited .

Consumer Insights: Understanding consumer behavior is pivotal. The report includes a comprehensive analysis of consumer trends, preferences, and purchasing patterns.

Market Segmentation- The report breaks down the Alzheimer?s Drugs market into key segments, providing a detailed examination of each segment's market size, Alzheimer?s Drugs market growth potential, and strategic considerations.On the Basis of Drug class this market is categorized further into-

Cholinesterase Inhibitors

NMDA Receptor Antagonists

Combination Drugs

and Pipeline Drugs

On the Basis of Distribution Channel this market is categorized further into-

Hospital Pharmacies

Retail Pharmacies

and Online Pharmacies

On the Basis of Geography this market is categorized further into-

North America

Europe

Asia Pacific

South & Central America

and Middle East & Africa

Key regions Alzheimer?s Drugs Market Research Report:

North America (U.S., Canada, Mexico)

Europe (U.K., France, Germany, Spain, Italy, Central & Eastern Europe, CIS)

Asia Pacific (China, Japan, South Korea, ASEAN, India, Rest of Asia Pacific)

Latin America (Brazil, Rest of Latin America)

The Middle East and Africa (Turkey, GCC, Rest of the Middle East and Africa)

Rest of the World

About Us:

The Insight Partners is a one-stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We specialize in industries such as Semiconductor and Electronics, Aerospace and Defense, Automotive and Transportation, Biotechnology, Healthcare IT, Manufacturing and Construction, Medical Devices, Technology, Media and Telecommunications, Chemicals and Materials.

#Alzheimer’s Drugs Market #Alzheimer’s Drugs Market Share #Alzheimer’s Drugs Market Size

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vanx-97 · 10 months

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I don't know how much longer it will be

I don't think you're ready to leave

From the stars above to the oceans beneath

There's still so much you need to see

This life we live is bitter sweet

It isn't always what we dream

There's some things we just can't keep

I just wish you could stay here with me

-By Me

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jcmarchi · 2 months

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Fixing Rogue Brain Cells May Hold Key to Preventing Neurodegeneration - Technology Org

New Post has been published on https://thedigitalinsider.com/fixing-rogue-brain-cells-may-hold-key-to-preventing-neurodegeneration-technology-org/

Fixing Rogue Brain Cells May Hold Key to Preventing Neurodegeneration - Technology Org

A team led by scientists at Case Western Reserve University School of Medicine has identified a new therapeutic approach for combating neurodegenerative diseases, offering hope of improved treatments for Alzheimer’s disease, Parkinson’s disease, Vanishing White Matter disease and multiple sclerosis, among others.

Astrocytes. Image credit: CWRU

Neurodegenerative diseases, which affect millions of people worldwide, occur when nerve cells in the brain or nervous system lose function over time and ultimately die, according to the National Institutes of Health. Alzheimer’s disease and Parkinson’s disease are the most common.

The research team’s new study, published online in Nature Neuroscience, focused on astrocytes—the brain’s most abundant cells that normally support healthy brain function. Growing evidence indicates astrocytes can switch to a harmful state that increases nerve-cell loss in neurodegenerative diseases.

The researchers created a new cellular technique to test thousands of possible medications for their ability to prevent these rogue astrocytes from forming.

“By harnessing the power of high-throughput drug screening, we’ve identified a key protein regulator that, when inhibited, can prevent the formation of harmful astrocytes,” said Benjamin Clayton, lead author and National Multiple Sclerosis Society career transition fellow in the laboratory of Paul Tesar at the Case Western Reserve School of Medicine.

They found that blocking the activity of a particular protein, HDAC3, may prevent the development of dangerous astrocytes. The scientists discovered that by administering medications that specifically target HDAC3, they were able to prevent the development of dangerous astrocytes and significantly increase the survival of nerve cells in mouse models.

“This research establishes a platform for discovering therapies to control diseased astrocytes and highlights the therapeutic potential of regulating astrocyte states to treat neurodegenerative diseases,” said Tesar, the Dr. Donald and Ruth Weber Goodman Professor of Innovative Therapeutics and the study’s principal investigator.

Tesar, also director of the School of Medicine’s Institute for Glial Sciences, said more research needs to be done before patients might benefit from the promising approach. But, he said, their findings could lead to the creation of novel therapies that disarm harmful astrocytes and support neuroprotection—perhaps improving the lives of people with neurodegenerative illnesses in the future.

“Therapies for neurodegenerative disease typically target the nerve cells directly,” Tesar said, “but here we asked if fixing the damaging effects of astrocytes could provide therapeutic benefit. Our findings redefine the landscape of neurodegenerative disease treatment and open the door to a new era of astrocyte targeting medicines.”

Source: Case Western Reserve University

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