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

NCT ID: NCT06810960

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-24

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lecanemab

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.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai Trial Site #1

Nutley, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Medical department Serena SoYoun Kwon

Role: CONTACT

+82-2-3451-5533

Other Identifiers

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BAN2401-M082-503

Identifier Type: -

Identifier Source: org_study_id

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