A Postmarketing Study of Lecanemab in South Korean Participants With Alzheimer's Disease

Not yet recruiting

• Conditions: Alzheimer's Disease

• Registration Number: NCT06810960
• Lead Sponsor: Eisai Korea Inc.

Brief Summary

The primary purpose of this study is to evaluate safety of lecanemab in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in participants treated with lecanemab.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-31
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 18 years or older at consent
• Prior to JOY-ALZ enrollment, the treating physician confirms that the participant is suitable for lecanemab treatment, as per the approved indications in South Korea
• Has an identified study partner who provides separate written informed consent
• Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.

Exclusion Criteria

• Currently participating in an interventional clinical study
• Has contraindications for lecanemab according to the approved prescribing information in South Korea

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events of Special Interest (AESIs)	Up to 6 years	AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Exposure-adjusted Incidence Rate of AESIs	Up to 6 years	AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.

Secondary Outcome Measures

Name	Time	Method
Incidence of Seizure, Anaphylaxis and Death	Up to 6 years
Exposure-Adjusted Incidence Rate of Seizure, Anaphylaxis and Death	Up to 6 years
Incidence of AESIs Based on Baseline Characteristics	Up to 6 years	Baseline characteristics will include apolipoprotein E4 (APOE4) genotype, baseline magnetic resonance imaging (MRI) findings, prior Alzheimer's disease (AD) treatments, and antithrombotic therapy.
Exposure-adjusted Incidence Rate of AESIs Based on Baseline Characteristics	Up to 6 years	Baseline characteristics will include APOE4 genotype, baseline MRI findings, prior AD treatments, and antithrombotic therapy.