The drug slows Alzheimer’s but can it make a real difference?

An experimental Alzheimer’s drug modestly slowed the inevitable worsening of brain disease, but it remains unclear how much difference this could make in people’s lives, researchers reported Tuesday.

Japanese drugmaker Eisai and its US partner Biogen announced earlier this fall that the drug lecanemab was working, a much-needed bright spot after repeated frustrations in the search for better Alzheimer’s treatments.

Now the companies are providing the full results of a study of nearly 1,800 people in the early stages of the mind-blowing disease. The data were presented at an Alzheimer’s meeting in San Francisco and published in The New England Journal of Medicine. US regulators may approve the drug in January.

Every two weeks for 18 months, study participants were given intravenous lecanemab or a sham infusion. Researchers tracked them using an 18-point scale that measures cognitive and functional ability.

Yale University’s Dr. The research team, led by Christopher van Dyck, concluded that those given lecanemab showed slower decline—a difference that wasn’t even half a point on this scale.

Eisai’s Dr. That’s an elusive change, but when measured differently, lecanemab delayed patients’ worsening by about five months over the course of the study, Michael Irizarry told the Associated Press. In addition, lecanemab recipients were 31% less likely to progress to the next stage of disease during the study.

“This means more time in the earlier stages, when people function better,” Irizarry said.

But doctors are divided on how much of a difference these changes could make for patients and families.

Stating that he is not speaking on behalf of the government agency, Dr. “The small difference reported in this trial is unlikely to be noticed by individual patients,” said Madhav Thambisetty.

He said many researchers believe meaningful improvement would require at least a full-point difference on this 18-point scale.

But an Alzheimer’s specialist at the Mayo Clinic, Dr. Ron Petersen said the drug’s effect is “modest, but I think clinically significant” — because even a few months’ delay in progress can buy a person a little more time. works independently.

Maria Carrillo, chief science officer of the Alzheimer’s Association, said the trial is important because it shows that a drug that attacks a sticky protein called amyloid, which is considered one of the few culprits behind Alzheimer’s, can delay the progression of the disease.

“We all understand that it’s not a cure, and we’re all trying to really grasp what it means to slow Alzheimer’s because it’s a first,” Carrillo said.

But any delay in early cognitive decline can make sense in terms of “how much time we have with loved ones in an illness phase where we can still enjoy family and trips, vacations, to-do lists.”

Amyloid-targeted drugs can cause side effects that include swelling and bleeding in the brain, and so did lecanemab. Some form of this swelling was seen in about 13% of recipients. Most are mild or asymptomatic, Eisai said.

In addition, two deaths were reported among lecanemab users who also took blood thinners for other health problems. Eisai said on Tuesday that the deaths could not be attributed to the Alzheimer’s drug.

But Petersen of Mayo said that if lecanemab is approved for use in the United States, it will avoid prescribing it to people who use blood thinners, at least initially.

And Thambisetty said reports of deaths raise concerns about how the drug might be tolerated outside of research studies where “patients are probably sicker and have many other medical conditions.”

The Food and Drug Administration is considering approving lecanemab under its accelerated program, and a decision is expected in early January. If approved, it would be the second anti-amyloid drug on the market.

For the 6 million Americans and millions of others worldwide with Alzheimer’s, nearly all available treatments relieve symptoms only temporarily. Scientists don’t yet know exactly how Alzheimer’s occurs, but one theory is that sticky amyloid buildup plays a key role, but every drug that targets it fails.

In a controversial move last year, the FDA approved Biogen’s Aduhelm, the first amyloid-targeting drug, despite the lack of evidence that patient outcomes are better. Insurers and many doctors were hesitant to prescribe the expensive drug – another reason why experts anxiously await news of how well the new lecanemab might work.

Petersen said that if the FDA approves lecanemab, patients and their families will need a voice in deciding whether the IV infusion is worth the trouble and the risk of side effects for at least some chance of delay in progression.

“I don’t think we can stop the disease where it is,” he added, with drugs that target amyloid alone, adding that he would take a combination of drugs that target the additional culprits of Alzheimer’s.

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

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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