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In this phase 3, industry-sponsored, multicenter, double-blind trial, researchers studied if lecanemab, a humanized immunoglobulin G1 monoclonal antibody targeting soluble amyloid-beta protofibrils, was safe and effective in treating early Alzheimer disease (AD). Participants met criteria for mild cognitive impairment (MCI) or mild dementia due to AD and had evidence of amyloid deposition on cerebrospinal fluid (CSF) or amyloid positron emission tomography (PET) imaging.
The 1795 participants (mean age, 71; about half female; about 75% white) were randomized 1:1 to 10 mg/kg of lecanemab or placebo every 2 weeks for 18 months. Approximately 80% of participants completed the study. The primary outcome was a change in the Clinical Dementia Rati…