Lecanemab does not significantly improve cognition in early Alzheimer's disease, is expensive, and causes brain edema and hemorrhage in some patients

Clinical Question

Is lecanemab safe and effective as a treatment of mild cognitive impairment or early Alzheimer's disease?

Bottom line

Similar to aducanumab, lecanemab does an excellent job of reducing amyloid while having very little impact on cognition and function, while causing concerning increases in brain edema and hemorrhage. The advisory committee from the United States Food and Drug Administration (FDA) voted almost unanimously against approval of aducanumab, a vote that was ultimately ignored by the FDA. This time, they didn't even convene an advisory committee and just went ahead and approved lecanemab. These decisions call into question the FDA's decision-making and independence, and also call into question the amyloid hypothesis for Alzheimer's disease. 1b

Study design: Randomized controlled trial (double-blinded)

Funding: Industry

Setting: Outpatient (any)

Reviewer

Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA


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Comments

Arup Kumar Dhara

Impact assessment

Very good

John Stevens

Once Again

Another expensive drug with questionable minimal benefits if any over time ... High risks ... But Big Pharma rules ...