Alzheimer’s Drug Slows Cognitive Decline in Key Study

In a briefing for reporters Tuesday night, Ivan Cheung, the chairman and chief executive of Eisai, said the results represented “the first definitively positive large clinical trial to show that you can indeed slow down Alzheimer’s disease at this very early symptomatic stage.”

He said that the drug started to show a benefit to patients about six months after they began taking it and that the benefit increased until the trial ended, 18 months after patients started on the drug.

The companies plan to present more detailed results in November.

Some experts said the drug’s ability to slow cognitive decline — by 0.45 on an 18-point scale — was modest at best and might not be a difference that patients in the mild early stages of the disease would notice.

Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, said the effect “is small and would not be considered by many as a minimally clinically important difference.” However, he added, “others would strongly disagree and say it’s clinically meaningful.”

Dr. Schneider said the “relatively low” rates of brain swelling and bleeding “suggest that lecanemab is easier to use” than Aduhelm.

He added that “although taking a press release at face value, which is often a chancy thing to do without having real data or reports, it seems that lecanemab would most likely receive regular marketing approval based on this one study alone.”

In the briefing, Mr. Cheung said the company considered the results “very clinically meaningful,” but he added, “Of course, there are different opinions out there on defining what clinical meaningfulness is for this stage of disease.”

Article source: https://www.nytimes.com/2022/09/27/business/alzheimers-drug-biogen-lecanemab.html