A Post Authorization Registry Study of Participants Treated With LEQEMBI

Condition(s) studied

Investigational drug(s) / intervention(s)

No Intervention: No intervention.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence and Severity of Known AEs — 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.

Trial sites (17)

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