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 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
ClinicalTrials.gov ID: NCT04468659
Sponsor: Eisai Inc.
Information provided by: Eisai Inc. (Responsible Party)
Last Update Posted: 2023-06-28
Brief 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).
Official Title:
AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study 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)
Intervention / Treatment :
- Drug: Lecanemab
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2020-07-14 |
| Primary Completion (Estimated) | 2027-10-25 |
| Study Completion (Estimated) | 2027-10-25 |
| Enrollment (Estimated) | 1400 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
BAN2401-G000-303
R01AG054029 (U.S. NIH Grant/Contract) R01AG061848 (U.S. NIH Grant/Contract) 2020-004244-28 (EudraCT Number) |