NCT04468659

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 Amyloid

AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study With an Extension Phase to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.

Conditions

• Preclinical Alzheimer's Disease
• Early Preclinical Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Lecanemab	IV infusion.
DRUG	Placebo	IV infusion.

Timeline

• Start date: 2020-07-14
• Primary completion: 2028-12-21
• Completion: 2031-01-16
• First posted: 2020-07-13
• Last updated: 2026-03-13

Locations

107 sites across 7 countries: United States, Australia, Canada, Japan, Singapore, Spain, United Kingdom

Regulatory

• FDA-regulated drug study