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

Part of paid clinical trials in Nutley, New Jersey.

Sponsor
Eisai Korea Inc.
Study ID
NCT06810960
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER
    This is a non-interventional study.

Study Details

The primary purpose of this study is to evaluate safety of LEQEMBI 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 patients treated with LEQEMBI.

Key Dates

Start date
Feb 24, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: LEQEMBI
    Patients with alzheimer's disease treated with LEQEMBI in accordance with the approved prescribing information by a physician in routine clinical practice (postmarketing). Data will be collected from the JOY-ALZ registry.

Primary Outcome Measure

Incidence of Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 6 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eisai Trial Site #1NutleyNew Jersey07110-

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