A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diagnostics [ALZ-NET] Registry Data)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Eisai Inc.
- 入组人数
- 6,700
- 试验地点
- 1
- 主要终点
- Incidence and exposure-adjusted incidence rate of the adverse events of special interest (AESIs) of ARIA-E, symptomatic ARIA-E, ARIA-H, symptomatic ARIA-H, and ICH greater-than 1 cm in diameter
研究概览
简要总结
The primary purpose of this study is to evaluate the safety of lecanemab-irmb 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 cm in participants treated with lecanemab-irmb.
The secondary purpose of this study is to:
Evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of seizures, anaphylaxis, central nervous system (CNS) ischemic event, and death.
Assess the safety of lecanemab-irmb when stratified by baseline characteristics including apolipoprotein E (APOE) genotype, baseline magnetic resonance imaging (MRI) findings consistent with a high risk for cerebral amyloid angiopathy (CAA), prior Alzheimer's Disease (AD) treatments, and antithrombotic therapy.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior AD treatment, and antithrombotic therapy within participants exposed to lecanemab-irmb in ALZ-NET.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and subjects exposed to lecanemab irmb in Study 301.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event,and death) between participants exposed to lecanemabirmb in ALZ-NET and subjects exposed to placebo (PBO) in Study 301.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and participants not exposed to anti-amyloid therapies in ALZ-NET.
Assess whether the risk of safety outcomes associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior Alzheimer's Disease treatments, and antithrombotic therapy differs between participants exposed to lecanemab-irmb in ALZ-NET versus those not exposed to anti-amyloid therapies in ALZ-NET.
详细描述
The study will use data from the ALZ-NET registry, which is expected to include about 20,000 patients being evaluated for- or treated with- new FDA-approved AD therapies. About 6,700 (33%) of these patients are expected to be 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in ALZ-NET
- •Either currently receiving or previously received lecanemab-irmb.
排除标准
- 未提供
研究组 & 干预措施
All Participants
Participants will be prescribed with lecanemab-irmb by physicians participating in the ALZ-NET registry based on the approved United States Prescribing Information (USPI).
干预措施: No Intervention (Other)
结局指标
主要结局
Incidence and exposure-adjusted incidence rate of the adverse events of special interest (AESIs) of ARIA-E, symptomatic ARIA-E, ARIA-H, symptomatic ARIA-H, and ICH greater-than 1 cm in diameter
时间窗: Baseline up to Follow-up, up to 10 years
次要结局
- Incidence and exposure-adjusted incidence rate of seizure, anaphylaxis, central nervous system (CNS) ischemic event, and Death(Baseline up to Follow-up, up to 10 years)
- Incidence Rate of AESIs(Baseline up to Follow-up, up to 10 years)