AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyl

• Status: Recruiting
• Trial end date: 2027-10-25

Summary

The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial).

• Phase: Phase 3

Details

• Lead Sponsor: Eisai Inc.
• Collaborators: Alzheimer's Clinical Trials Consortium; Alzheimer’s Clinical Trial Consortium (ACTC); Biogen; National Institute on Aging (NIA)