A 6-Year Postmarketing Safety and Clinical Outcome Study of Lecanemab in the Treatment of Alzheimer's Disease Using Real-World Data From South Korean Patients Enrolled Into the South Korean JOint RegistrY for ALZheimer's Treatment and Diagnostics (JOY-ALZ) Registry

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Eisai Trial Site #1
RECRUITING
Nutley
Contact Information
Primary
Medical department Serena SoYoun Kwon
s-kwon@eisaikorea.com
+82-2-3451-5533
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 3000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Eisai Korea Inc.

This content was sourced from clinicaltrials.gov