An Observational Study of LEQEMBI in Routine Clinical Practice in Taiwan

StatusNot Yet Recruiting
PhaseNot specified
Started

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Record History

  1. Minor Study First Submitted
42 trials monitored
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1,982 trials monitored
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The primary purpose of this study is to describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities (ARIA)-oedema/effusion (ARIA-E), ARIA-microhemorrhage and haemosiderin deposit (ARIA-H), intracerebral hemorrhage greater than 1 cm, and anaphylaxis (stratified by apolipoprotein E4 variant \[APOE4\] genotype, concomitant antithrombotic therapy, and comorbid cerebral amyloid angiopathy \[CAA\]), in participants treated with LEQEMBI in routine clinical practice in Taiwan. To describe previously unknown adverse events 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 progression to the next stage of Alzheimer's Disease (AD) in routine clinical practice. To describe drug utilization of LEQEMBI and effectiveness of risk minimization measures in routine clinical practice.
Trial Details
NCT Number NCT07869264
Lead Sponsor Eisai Taiwan Inc.
Conditions
(from sponsor)
Alzheimer's Disease
Related terms Alzheimer Disease
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov