RECRUITINGOBSERVATIONAL
A Postmarketing Study of Lecanemab in South Korean Participants With Alzheimer's Disease
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
- Provides written willing to sign a consent form for the use of medical information to be shared with Eisai Korea Inc.
Who Should NOT Join This Trial:
- Currently participating in an interventional clinical study
- Has contraindications for lecanemab according to the approved prescribing information in South Korea
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
No Intervention
This is a non-interventional study.
Locations (1)
Eisai Trial Site #1
Nutley, New Jersey, United States