A 6-Year Postmarketing Safety and Clinical Outcome Study of LEQEMBI® 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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events of Special Interest (AESIs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Currently participating in an interventional clinical study
研究组 & 干预措施
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.
干预措施: No Intervention (Other)
结局指标
主要结局
Incidence of Adverse Events of Special Interest (AESIs)
时间窗: 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
时间窗: Up to 6 years
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
次要结局
- Incidence of Seizure, Anaphylaxis and Death(Up to 6 years)
- Exposure-Adjusted Incidence Rate of Seizure, Anaphylaxis and Death(Up to 6 years)
- Incidence of AESIs Based on Baseline Characteristics(Up to 6 years)
- Exposure-adjusted Incidence Rate of AESIs Based on Baseline Characteristics(Up to 6 years)
- Incidence of Adverse Events (AEs), Adverse drug reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs)(Up to 6 years)
- Exposure-Adjusted Incidence Rate of AEs, ADRs, SAEs, SADRs(Up to 6 years)
- Incidence of AEs and ADRs That are not Reflected in the Approved Prescribing Information(Up to 6 years)
- Exposure-Adjusted Incidence Rate of AEs and ADRs That are not Reflected in the Approved Prescribing Information(Up to 6 years)
- Incidence of ARIA-Related Events by Baseline Characteristics(Up to 6 years)
- Exposure-Adjusted Incidence Rate of ARIA-Related Events by Baseline Characteristics(Up to 6 years)
- Incidence of AEs by Baseline Characteristics(Up to 6 years)
- Exposure-Adjusted Incidence Rate of AEs by Baseline Characteristics(Up to 6 years)