With an aging population, the incidence of dementia is increasing. While not all of the “old age foibles” and related mental difficulties are technically Alzheimer’s, we clearly hear more about it today than just a couple of decades ago. And those who have relatives who’ve had Alzheimer’s know of the emotional pain it creates for everyone. Here’s last November’s good news about some medical breakthroughs. I’ll add “to do” comments afterwards.
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Rare success for Alzheimer’s research
unlocks hope for future therapies
Reuters
29 November, 2022
CHICAGO: The first big breakthrough in 30 years of Alzheimer’s research is providing momentum for clinical trials of “cocktail” treatments targeting the two hallmark proteins associated with the mind-robbing disease, according to interviews with researchers and pharmaceutical executives.
Drugmakers Eisai Co Ltd and Biogen reported in September that their therapy lecanemab could slow progress of the disease by 27% over 18 months compared with a placebo.
The finding validates the theory that clearing the amyloid protein that forms clumps in the brains of Alzheimer’s patients could slow or halt the disease and has strengthened the support from some scientists for simultaneously targeting another notorious protein linked to Alzheimer’s: tau.
Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer’s Disease conference in San Francisco. The U.S. Food and Drug Administration is expected to make a decision by early January on the companies’ application for accelerated approval.
If approved on an accelerated basis, the companies said they would immediately apply for full U.S. regulatory approval which could help secure Medicare coverage. Dr. Reisa Sperling, a neurologist and Alzheimer’s researcher at Harvard Medical School, said in an interview …
“I think lecanemab has reinvigorated
the idea that now you could do a
combination of amyloid (and) tau.”
Tau naturally accumulates in a memory center of the brain called the medial temporal lobe as people age. A growing body of research suggests that rising levels of amyloid in Alzheimer’s patients act as an accelerant, causing an explosive spread of tau that forms toxic tangles inside brain cells, eventually killing them. Sperling said …
“We’ve been trying to do combination
trials for years. Nearly a decade ago,
Alzheimer’s experts met in Washington
to discuss testing combined therapies.
At the time, no one would listen.”
Now, however, Sperling and other researchers in the Alzheimer’s Clinical Trials Consortium (ACTC), a research network backed by the National Institute on Aging, say drugmakers are increasingly interested in participating in a study to test tau drugs alone and in combination with anti-amyloid drugs such as lecanemab.
Dr. Paul Aisen, director of the Alzheimer’s Therapeutic Research Institute at the University of Southern California’s Keck School of Medicine, and a leader with Sperling of the ACTC, said …
“We’ve been talking to multiple companies
about working with us on our proposed
platform, which can evaluate multiple
drugs, and everybody’s interested.”
Eisai’s trial success raises hope for Alzheimer’s prevention
The scientists said they expect an answer on funding by year-end. NIH said it does not discuss grants under review.
More than 6 million Americans have Alzheimer’s, costing the U.S. economy nearly $6 billion a year in direct spending and unpaid caregiving expenses, according to congressional briefing documents. By 2050, Alzheimer’s cases are expected to double to 12.7 million, bringing the total yearly cost to nearly $1 trillion, according to the documents.
Last year, the FDA gave Biogen and Eisai’s drug aducanumab conditional approval even though it failed one of its two late-stage trials. The approval was based on the drug’s ability to remove amyloid from the brain.
Biogen initially priced the drug at $56,000 a year, but the U.S. Centers for Medicare and Medicaid Services said it needed more compelling evidence, and that Medicare would only cover the drug for use in clinical trials.
Lecanemab’s success rests on years of research into the causes of Alzheimer’s as well as advances in measuring amyloid deposits through brain scans and spinal fluids. Trials of tau drugs will aim to build on that progress, using brain scans, spinal fluids and blood tests to better assess the stage of disease, when to intervene and whether the drug is hitting its target.
That would allow companies to test drugs even before symptoms emerge.
Nearly a dozen drugmakers, including Roche, Merck & Co, Johnson & Johnson and Eli Lilly and Co, are working on therapies that target tau. At least 16 treatments are being tested in clinical trials, with results expected over the next three years, according to a Reuters review of the clinicaltrials.gov registry.
Merck is testing its MK-2214 therapy aimed at clearing tau in patients in very early stages of the disease in several small trials. Jason Uslaner, Merck’s head of discovery neuroscience, said the drugmaker has been largely absent from the Alzheimer’s space after the high-profile failure of its drug verubecestat five years ago.
“The understanding of the disease is getting
much, much better. So far, only a few trials
combine an amyloid-lowering therapy with a
drug that targets tau in a “cocktail” approach,
similar to those used against cancers and HIV.”
Such combinations may improve on the benefit of lowering amyloid alone in people who have symptoms, researchers told Reuters. And when used earlier in the disease, the hope is that they might prevent dementia altogether. Dr. Adam Boxer, a tau expert at the University of California San Francisco (UCSF) Memory and Aging Center, said …
“It may be that you need both – the
removal of amyloid that’s driving that
biological cascade – and you need
to clean up any tau that’s already
spreading from one cell to another.”
But several antibody therapies from Lilly, Biogen and AbbVie that were designed to slow the rate of tau accumulations failed outright last year. A drug from Roche, semorinemab, showed limited effectiveness. Boxer said …
“It took maybe 20 or 30 years before
we found a drug that really targeted
the right form of amyloid to make
a difference. It’s still early days.”
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While the Reuters report is many months old, the issues are still relevant. My question is: Even before the drugs are approved and made available, what can most of us do, even before the official onset of Alzheimer’s, to prevent it from happening? Some comments from D …
“First, to help prevent Alzheimer’s and other forms of dementia, exercise has been proven to help. Walking almost every day for 30-40 minutes can make a huge difference in prevention.
“Second, eating a moderated natural foods diet, similar to the Mediterranean diet, has also shown to be helpful in prevention.
“And third, stress management – specifically meditation – has also been shown to be helpful.
“Now, one might ask: Why these three things?
“And the answer is: A body moving keeps joints looser and blood flowing, giving yourself stronger muscles to maintain your health. Eating a Mediterranean diet (vs highly processed foods) keeps many toxins out of the body. In addition to food, ensuring you stay hydrated is critical for all body functions.
“And finally, stress management is needed for mental health. All you really need is about ten minutes a day. Over time, it builds resiliency in your brain, to more effectively address stress when it arrives … as it will.”
I’ll also add … I’ve read that mental exercises that challenge you – such as crossword puzzles or Scrabble – will keep your brain more active and may help deter most forms of dementia. (If crossword puzzles were good enough for Alan Turing, they’re certainly good enough for me!)
