Clinical Research Directory

A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease

Sponsor: Eisai Inc.

Summary

The primary purpose of this study is to evaluate the efficacy of LEQEMBI in participants with early Alzheimer's disease (AD) indicated per Canada Product Monograph (APOE4 non-carriers and heterozygotes; indicated population) compared with placebo (PBO)-treated participants from BAN2401-G000-301 (Study 301) Core study on change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment.

Official title: A Postmarketing Study to Confirm Treatment Benefit and Fulfill Conditions Associated With Market Authorization in Canada for LEQEMBI (Lecanemab) Administered in Adult Patients With a Clinical Diagnosis of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease (Early Alzheimer's Disease), Who Are Apolipoprotein Epsilon 4 (ApoE Epsilon 4) Noncarriers or Heterozygous Carriers With Confirmed Amyloid Pathology

Key Details

Conditions

Interventions

Locations (1)