A 6-Year Safety Study of LEQEMBI for Alzheimers Disease Using Real-World Data from South Korean Patients in the JOY-ALZ Registry

What this Trial Is About

Researchers are evaluating the safety of LEQEMBI in patients with Alzheimers disease in a real-world clinical setting. The study focuses on tracking specific events related to amyloid-related imaging abnormalities ARIA, including ARIA-edema ARIA-E, ARIA-hemosiderin deposition ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage larger than 1 centimeter. The aim is to gather safety data over a long period while patients receive LEQEMBI treatment. This is an observational, non-interventional study where patients with Alzheimers disease are treated with LEQEMBI according to the approved prescribing information by their physician during routine clinical practice. Data will be collected from the South Korean JOY-ALZ registry, which tracks patients receiving this treatment. There is no placebo or comparator group, and treatment decisions are made prior to enrollment. Participants will be followed for up to 6 years, during which researchers will monitor and record the incidence and rates of adverse events of special interest, including ARIA-related events and other adverse drug reactions. They will also observe serious adverse events and reactions. The study collects real-world data to better understand the safety profile of LEQEMBI over time in the South Korean population with Alzheimers disease.

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