Clinical Research Directory

An Observational Study of LEQEMBI in Routine Clinical Practice in Taiwan

Sponsor: Eisai Taiwan Inc.

Summary

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.

Official title: An Observational Registry Study to Evaluate the Use and Safety of LEQEMBI in Routine Clinical Practice in Taiwan

Key Details

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Interventions

Locations (12)