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CLARITY-AD
About the Trial
The Clarity AD trial randomized 1,795 early Alzheimer patients to the anti amyloid antibody lecanemab or placebo for 18 months. Lecanemab slowed clinical decline by 27 percent on the CDR SB scale and improved secondary endpoints including amyloid PET clearance. ARIA edema or hemorrhage occurred in 21 percent, mostly asymptomatic, with rare deaths in anticoagulated patients. After decades of failed amyloid trials, aducanumab controversy included, lecanemab delivered an unambiguous positive result and FDA traditional approval in 2023. Donanemab followed. The trial rekindled the amyloid cascade debate but undeniably opened the disease modifying therapy era for Alzheimer disease.
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