NCT03887455

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,906 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.

Detailed description

All administrations of study drug will be administered in the clinic or in the home; However, home administrations of intravenous (IV) study drug will be allowed per sponsor approval according to country and local guidelines during the COVID-19 pandemic and following its resolution, where permitted.

Conditions

• Early Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Lecanemab IV	Administered as IV infusion.
DRUG	Placebo	Biweekly (once every 2 weeks) administered as IVinfusion.
DRUG	Lecanemab SC	Administered weekly as a SC injection.

Timeline

• Start date: 2019-03-27
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2019-03-25
• Last updated: 2026-04-07

Locations

247 sites across 14 countries: United States, Australia, Canada, China, France, Germany, Italy, Japan, Russia, Singapore, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study