Donanemab and Solanezumab in Alzheimer Disease

Two new randomized, double-blind, placebo-controlled, industry-sponsored phase 3 clinical trials investigated the clinical efficacy of the non–FDA-approved drugs donanemab and solanezumab, respectively, in clinical or preclinical Alzheimer disease (AD).

In the first study, participants with early symptomatic AD ages 60 to 85 years with amyloid and tau deposition on ¹⁸F-florbetapir or ¹⁸F-florbetapen and ¹⁸F-flortaucipir positron-emission tomography (PET) scans received either intravenous donanemab (700 mg for 3 doses and 1400 mg thereafter) or placebo every 4 weeks for up to 76 weeks. Donanemab participants switched to placebo upon dose completion. Among 1736 participants (about 57% female; 68% with low/medium tau pathology; 32% with high ta…