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

Eisai

Status: Enrolling

Conditions: Alzheimer's Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06810960

BAN2401-M082-503

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Lecanemab

Description:

Participants treated with lecanemab in accordance with the approved prescribing information by a physician in routine clinical practice (postmarketing). Data will be collected from by JOY-ALZ registry.

Treatment:

Other: No Intervention