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

Early Alzheimer's Disease Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

All administrations of study drug will be administered in the clinic; However, home administrations of 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03887455
Study type	Interventional
Source	Eisai Inc.
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	March 27, 2019
Completion date	September 15, 2027

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See also
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Active, not recruiting	`NCT04770220` - An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects	Phase 3
Active, not recruiting	`NCT04777396` - A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)	Phase 3
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Recruiting	`NCT04599764` - High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease	N/A
Completed	`NCT05161715` - Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease	Phase 2
Completed	`NCT02859207` - A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects	Phase 1
Enrolling by invitation	`NCT06304883` - Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects	Phase 3