A Prospective Observational Registry Study to Evaluate the Use and Safety of LEQEMBI in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Incidence and Severity of ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis
研究概览
简要总结
The primary purpose of the study is to describe the incidence and severity of known adverse events (AEs), including Amyloid-Related Imaging Abnormalities Oedema/Effusion (ARIA-E), Amyloid-Related Imaging Abnormalities-Microhemorrhage and Haemosiderin Deposit (ARIA-H), intracerebral hemorrhage greater than (>) 1 centimeter (cm) in diameter, and anaphylaxis (stratified by apolipoprotein E4 variant [APOE4] genotype, concomitant antithrombotic therapy, and comorbid Cerebral Amyloid Angiopathy [CAA]), of LEQEMBI in routine clinical practice.
详细描述
This is a Post-Authorisation Safety Study registry designed to evaluate the safety, benefit-risk profile, drug utilisation, and effectiveness of risk minimisation measures of LEQEMBI in patients with AD in routine clinical practice
The secondary purposes of the study are:
- To describe the benefit-risk profile of LEQEMBI in routine clinical practice across patient subgroups as determined by progression to the next stage of AD (stratified by APOE4 genotype, concomitant antithrombotic therapy, and comorbid CAA).
- To describe previously unknown AEs related to long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions and adverse reactions leading to discontinuation of LEQEMBI treatment.
- To describe drug utilisation of LEQEMBI and effectiveness of risk minimisation measures in routine clinical practice.
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
- •The participant (and/or legally authorised representative) has provided written informed consent to participate in the Post-Authorisation Safety Study (PASS) and for use of their protected health information (PHI).
- •The participant is registered in the Controlled Access Programme (CAP) and has been prescribed LEQEMBI.
排除标准
- •Participation or planning to participate in randomised controlled trials (RCTs) for mild cognitive impairment (MCI) or AD, and patients who have had prior exposure to anti-amyloid monoclonal antibody (mAb) treatment including prior use of lecanemab.
结局指标
主要结局
Incidence and Severity of ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis
时间窗: Up to 3 years
次要结局
- Time to Progression to the Next Stage of Alzheimer's Disease (AD)(Up to 3 years)
- Incidence and Severity of Serious Suspected Adverse Reactions and Adverse Reactions Leading to Discontinuation of LEQEMBI Treatment(Up to 3 years)
- Drug Utilisation of LEQEMBI Based on Baseline Characteristics(Up to 3 years)
- Duration of Treatment(Up to 3 years)
- Incidence of Serious ARIA and ICH(Up to 3 years)
- Effectiveness of Risk Minimization Measures(Up to 3 years)