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

Preclinical Alzheimer's Disease Clinical Trial

Official title:
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 Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Alzheimer Disease
Amyloidosis
Early Preclinical Alzheimer's Disease
Preclinical Alzheimer's Disease

Clinical Trial Details

NCT number	NCT04468659
Study type	Interventional
Source	Eisai Inc.
Contact	Eisai Medical Information
Phone	+1-888-274-2378
Email	esi_medinfo@eisai.com
Status	Recruiting
Phase	Phase 3
Start date	July 14, 2020
Completion date	February 15, 2029

View Details

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