Lecanemab (BAN2401) in Early Alzheimer's Disease (Clarity AD)

Phase 3 Completed

Early Alzheimer's Disease

NCT ID NCT03887455 ↗

Phase Phase 3

Status Completed

Sponsor Eisai / Biogen

Enrolment n = 1,795

Last updated 2026-04-30

Registered 2026-04-30

Target intervention

Lecanemab (anti-amyloid monoclonal)

Primary endpoint

CDR-Sum of Boxes change from baseline at 18 months

Summary

Anti-amyloid monoclonal that achieved 27% slowing on CDR-SB; led to traditional FDA approval July 2023. Defined the post-amyloid AD-disease-modifying era.

Protocol timeline

Phase I

Phase II

Phase III

Phase IV

Current status Completed

Enrolled n = 1,795

View on ClinicalTrials.gov ↗

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