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The amyloid debate’s next phase: presymptomatic Alzheimer’s disease

ARTICLE | Regulation

FDA guidance suggests identifying asymptomatic patients via biomarkers. Could digital endpoints and patient-reported outcomes fill the gap?

By Selina Koch, Executive Editor

June 13, 2024 12:43 AM UTC

Ask virtually anyone in the Alzheimer’s drug development community and they’ll tell you that anti-amyloid mAbs promise the most benefit when used early in disease, ideally before symptoms start. But how many healthy people should be exposed to a drug class with serious safety risks to prevent a fraction of them from becoming symptomatic?

That question is at the heart of the debate around FDA’s recent draft guidance on developing drugs for the earliest stages of Alzheimer’s disease.