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A Post Authorization Registry Study of Participants Treated With LEQEMBI

2026年8月12日 更新者：Eisai Limited

Post Authorization Registry Study of Patients Treated With LEQEMBI

To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy [CAA]).

The secondary purpose of this study is,

To describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.

To describe previously unknown adverse events related to the long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment (regardless of causality).

To describe drug utilization of LEQEMBI and to assess the effectiveness of risk minimization measures in routine clinical practice.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a noninterventional, prospective, observational Patient Registry study that will be conducted in Canada, the main purpose of which is to describe the incidence and severity of known adverse events in participants treated with LEQEMBI during routine clinical practice.

研究类型

观察性的

注册 (估计的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • University of British Columbia - CARD
      • Victoria、British Columbia、加拿大
        • UBC Victoria - Neil and Susan Manning Cognitive Health Initiative
    • Ontario
      • London、Ontario、加拿大
        • Parkwood Hospital - London
      • Mississauga、Ontario、加拿大
        • Trillium Hospital
      • Ottawa、Ontario、加拿大
        • Bruyère Institute
      • Peterborough、Ontario、加拿大
        • Kawartha Center
      • Toronto、Ontario、加拿大
        • Toronto Memory Program
      • Toronto、Ontario、加拿大
        • Toronto Western Hospital
      • Toronto、Ontario、加拿大
        • Sunnybrook Hospital
    • Quebec
      • Montreal、Quebec、加拿大
        • McGill University, Douglas Mental Health
      • Québec、Quebec、加拿大
        • CHU de Québec-Université Laval Research Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada and are enrolled into the Patient Registry.

描述

Inclusion Criteria:

  • Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.

Exclusion Criteria:

  • None

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Participants Treated With LEQEMBI
Participants treated with LEQEMBI in Canada
其他：无干预
无干预措施。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence and Severity of Known AEs
大体时间：Up to 3 years
Incidence and severity of known AEs will be reported. AEs will include ARIA-E and ARIA-H (including asymptomatic and symptomatic) and ICH >1 cm in diameter in participants treated with LEQEMBI.
Up to 3 years

次要结果测量

结果测量
措施说明
大体时间
Time to Progression to the Next Stage of Alzheimer's Disease
大体时间：Up to 3 years
Up to 3 years
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
大体时间：Up to 3 years
Incidence and severity of serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment.
Up to 3 years
Drug Utilization of LEQEMBI
大体时间：Up to 3 years
Drug utilization will be assessed by count (n) and proportion (%) of age, ethnicity, sex, residential location, APOE4 genotype, AD diagnosis, baseline MRI findings, baseline antithrombotic use, participants prescribed LEQEMBI according to PM, and treatment discontinuation by reason.
Up to 3 years
Duration of Treatment
大体时间：Up to 3 years
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment
Up to 3 years
Effectiveness of Risk Minimization Measures
大体时间：Up to 3 years
Effectiveness of Risk Minimization Measures will be assessed by the proportion of participants using antithrombotic medications during treatment, demonstrating compliance with MRI monitoring (before the 3rd, 5th, 7th, and 14th infusions), with dose suspension or discontinuation of LEQEMBI for ARIA or ICH >1 cm, and reporting physician compliance with providing educational materials at treatment initiation and after safety updates (if applicable), including type of materials, distribution method, and quantity.
Up to 3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eisai Limited

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月31日

初级完成 (估计的)

2036年4月1日

研究完成 (估计的)

2036年4月1日

研究注册日期

首次提交

2026年7月20日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月13日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BAN2401-A001-506

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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