Clinical Trials in the USA / NCT06810960
Recruiting
Observational
A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease
NCT06810960 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Alzheimer's Disease
Investigational drug(s) / intervention(s)
No Intervention
No Intervention: This is a non-interventional study.
Study 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.
Eligibility
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
Primary outcome measure(s)
- Incidence of Adverse Events of Special Interest (AESIs) — Up to 6 years
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm. - Exposure-adjusted Incidence Rate of AESIs — Up to 6 years
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Eisai Trial Site #1 | Nutley | New Jersey | Recruiting |
Other trials for the same condition
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
Active, not recruiting
A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06810960 on ClinicalTrials.gov ↗ ← All trials in the USA