Dec 5, 2022 4 min read

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Researchers have reported an experimental Alzheimer’s drug modestly slowed the brain disease’s inevitable worsening – the next question is how much difference that might make in people’s lives.

A researcher, who in the early ’90s helped uncover the mutation that helped lead to the formulation of the drug, has hailed the results and says they are “turning the curve” on treating Alzheimer’s.

Japanese drugmaker Eisai and its U.S. partner Biogen announced earlier this autumn that the drug lecanemab appeared to slows Alzheimer’s, a badly needed success after repeated disappointments in the quest for better Alzheimer’s treatments.

Now, researchers are getting their first peek at the full results of the study of nearly 1,800 people in the earliest stages of the mind-robbing disease.

The data was presented at an Alzheimer’s meeting in San Francisco and published in the New England Journal of Medicine.

Every two weeks for 18 months, study participants received intravenous lecanemab or a dummy infusion.

Researchers tracked them using an 18-point scale that measures cognitive and functional ability.

Those given lecanemab declined more slowly – a difference of not quite half a point on that scale, concluded the research team, led by Dr. Christopher van Dyck at Yale University.

Lecanemab recipients were 31% less likely to advance to the next stage of the disease during the study.

In the early ’90s, John Hardy, now professor of neuroscience at UCL’s Institute of Neurology, was part of a team that first found the amyloid mutation in Alzheimer’s disease.

They hypothesized if you could clear amyloid away from the brain, there could be a beneficial clinical effect.

“If you’d asked me 30 years ago how long it would take, I’d say five to 10 years. So, for me, it seems definitely momentous. I think for patients, it’s a real step forward,” says Hardy, who was not involved with the trial, but has consulted with drugmaker Eisai.

“Amyloid is driving the disease. It’s pushing all the other pathology. So, it’s like taking your foot off the accelerator pedal, basically. And so, the amyloid goes down and so the foot comes off the accelerator pedal and it gradually slows down.”

But doctors are divided over how much difference those changes may make for patients and families.

Amyloid-targeting drugs can cause side effects that include swelling and bleeding in the brain, and lecanemab did as well in about 13% of recipients. Eisai said most were mild or asymptomatic.

Also, two deaths have been publicly reported among lecanemab users who also were taking blood-thinning medications for other health problems. Eisai said recently the deaths can’t be attributed to the Alzheimer’s drug.

In the United States the Food and Drug Administration is considering accelerated approval of lecanemab, with a decision expected in early January. If approved, it would be the second anti-amyloid drug on the market.

In a contentious move last year, the FDA approved the first amyloid-targeting drug, Biogen’s Aduhelm, despite lack of evidence of better patient outcomes.

Insurers and many doctors have hesitated to prescribe the pricey Aduhelm – another reason experts have anxiously awaited word of how well the newer lecanemab may work.

Hardy predicts it will also be expensive.

“It is going to be a costly drug, I would guess. It’s also going to be costly to administer, because you have to do the safety monitoring and all that sort of stuff. You have to do all the tests to make sure that you have people with Alzheimer’s disease and not some other cause of dementia. So, both the drug costs, which are going to be reasonably expensive and also the monitoring and the administrative, you know, for administering the drug, those costs as well,” says Hardy.

Nearly all treatments available for the six million Americans with Alzheimer’s, and millions more worldwide, only temporarily ease symptoms.

“I would say the immediate comfort, and this is something I’m really attuned to, is for the families where we found mutations. I think we can say to their children, the next generation, that’s something we can say now, I think. Their next generation are going to have something which is going to alleviate at least some of the problems of the disease,” says Hardy.

“More generally, for Alzheimer’s disease, I think that we can see that we are turning the curve and it’s going to get better.”

Researchers are preparing to test lecanemab with other experimental drugs, and how it works in high-risk people before they show the first signs of memory problems.