Recruiting

Lecanemab

Sponsor:

Eisai Korea Inc.

Code:

NCT06810960

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

Brief summary:

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.

Conditions

Alzheimer's Disease

Study ID

NCT06810960

Start date

Feb 24, 2025

Status verified date

Apr, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Enrolled in JOY-ALZ before the decision to treat with LEQEMBI
  • The clinical decision to treat with LEQEMBI has already been made
  • 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

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

No Intervention

This is a non-interventional study.

Primary outcome measure

  • Incidence of Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 6 years ]
  • Exposure-adjusted Incidence Rate of AESIs [ Time Frame: Up to 6 years ]

Central Contacts and Locations

Central contacts

Eisai Korea Inc. Medical department Serena SoYoun Kwon

+82-2-3451-5533s-kwon@eisaikorea.com

Locations

Eisai Trial Site #1

Recruiting

Nutley, New Jersey, United States, 07110

More Information

Sponsor

Eisai Korea Inc.

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Alzheimer's Disease
  • LEQEMBI
  • ARIA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eisai Korea Inc. on 2026-04-21.