A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Trial ID or NCT#

NCT03887455

Status

recruiting iconRECRUITING

Purpose

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

Official Title

A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Eligibility Criteria

Ages Eligible for Study: 50 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Sharon Sha, MD, MS
Sharon Sha, MD, MS
Memory disorders specialist, Movement disorders specialist
Clinical Professor, Neurology & Neurological Sciences