Donanemab in Early Alzheimer Disease

Donanemab is an investigational (not FDA-approved) humanized antibody directed at an epitope present only in established amyloid plaques, a pathological finding in Alzheimer disease (AD). In this randomized, double-blind, industry-sponsored phase 2 clinical trial, researchers investigated the safety and efficacy of donanemab in patients aged 60 to 85 years who had early AD with amyloid and tau deposition on ¹⁸F-florbetapir and ¹⁸F-flortaucipir positron-emission tomography. The 257 mostly white participants received intravenous donanemab (700 mg for the first 3 doses) or placebo every 4 weeks for up to 72 weeks. The primary outcome was a change in scores on an integrated cognitive and activities-of-daily-living scale (Integrated Alzheimer's …