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In 2021, approval of the anti-amyloid antibody aducanumab (Aduhelm) for early Alzheimer disease was highly controversial: Although it reduced amyloid plaque burden, its effect on cognition was considered to be clinically unimportant by critics. Now, a second anti-amyloid antibody — lecanemab (Leqembi) — has been FDA-approved, based on this phase 3 trial.
Nearly 1800 people with early Alzheimer disease and objective evidence of amyloid plaques were randomized to lecanemab or placebo, given intravenously every 2 weeks. The primary outcome was change on a standardized 18-point dementia rating scale that assesses memory, other aspects of cognition, and function. From mean scores of 3.2 at baseline, scores at 18 months increased (indicating great…