An experimental Alzheimer’s drug has slowed the inevitable deterioration of the brain disease, researchers reported Tuesday — but it’s unclear how much of a difference it will make in people’s lives.
Japanese drugmaker Eisai and its American partner Biogen announced This fall After repeated disappointments in the search for a better Alzheimer’s treatment, the drug lecanemab seemed to work.
The companies are now presenting the full results of a study of nearly 1,800 people in the early stages of the mind-robbing disease. The data were presented at the Alzheimer’s Meeting in San Francisco and published in The New England Journal of Medicine. US regulators could approve the drug as early as January.
Every two weeks for 18 months, study participants received an intravenous infusion of lecanemab or a sham. The researchers tracked them using an 18-point scale that measures cognitive and functional ability.
Those given lecanemab declined much more slowly — not even half a point difference on that scale, the research team led by Dr. Christopher Van Dyck at Yale University concluded.
It’s an unexplained change, but measured differently, lecanemab delayed deterioration in patients by about five months during the study, Eisai’s Dr. Michael Irizarry told The Associated Press. Also, those receiving lecanemab were 31% less likely to progress to a later stage of the disease during the study.
When people perform better, “it translates to more time at earlier stages,” Irisari said.
But doctors are divided on how much of a difference those changes will make to patients and families.
“The small difference reported in this trial is unlikely to be noticed by individual patients,” said Dr. Madhav Thambisetty of the National Institute on Aging, who noted that he did not speak for a government agency.
He said many researchers believe that a meaningful improvement would require a difference of at least one full point on that 18-point scale.
But Mayo Clinic Alzheimer’s specialist Dr. Ron Peterson said the drug’s effect is “very modest, but I think it makes clinical sense” — even if it’s delayed by a few months, it gives someone a little more time. operate independently.
The test is important because it shows the drug attacks a sticky protein called amyloid — Considered one of many criminals Behind Alzheimer’s disease — it can delay disease progression, said Maria Carrillo, the Alzheimer’s Association’s chief scientific officer.
“We all understand that this is not a cure, and we’re all trying to understand what it means to slow Alzheimer’s because it’s the first time,” Carrillo said.
But a delay in cognitive decline can make sense because “at one stage of the disease we can still enjoy spending time with our loved ones, family and outings, vacations, and bucket lists.”
Amyloid-targeting drugs can cause side effects including swelling and bleeding in the brain, and so did lecanemab. A form of this inflammation was seen in about 13% of recipients. Most are mild or asymptomatic, Esai said.
Also, two deaths have been publicly reported among lecanemab users who took blood thinners for other health problems. Esai said Tuesday that the deaths could not be attributed to the Alzheimer’s drug.
But Mayo’s Peterson says that if lecanemab is approved for use in the U.S., he would avoid prescribing it in the first place for people on blood thinners.
Thambisetty said the death reports raise concerns about how well the drug might be tolerated outside of research studies “where patients may be sick and have multiple medical conditions.”
The Food and Drug Administration is considering approving lecanemab under its fast-track program, with a decision expected in early January. If approved, it would be the second anti-amyloid drug on the market.
Almost all available treatments for the 6 million Americans with Alzheimer’s — and millions more worldwide — only temporarily ease symptoms. Scientists still don’t know exactly how Alzheimer’s develops, but one theory is that gunky amyloid formation plays a key role, though drug after drug has failed.
If the FDA approves lecanemab, patients and their families will need a voice in determining the risk of side effects for the hassle of IV infusions and the possibility of a slight delay in progress, Peterson said.
“I don’t think we’re going to stop the disease in its tracks with amyloid-targeted drugs,” he said, adding that it would take a combination of drugs targeting additional Alzheimer’s culprits.
Researchers are preparing to test lecanemab with other experimental drugs to see how it works in high-risk individuals before they show the first signs of memory problems.
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