About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Participants with AD who are prescribed LEQEMBI by a physician in routine clinical practice in the UK.
Trial design
Cohort
Prospective
Treatments tested in this trial
No Intervention
Other interventionNo intervention.
Treatment groups
Trial outcomes
Primary outcomes
Incidence and Severity of ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis
Secondary outcomes
Time to Progression to the Next Stage of Alzheimer's Disease (AD)
Incidence and Severity of Serious Suspected Adverse Reactions and Adverse Reactions Leading to Discontinuation of LEQEMBI Treatment
Drug Utilisation of LEQEMBI Based on Baseline Characteristics
Baseline demographics will include age/age group, sex, race, ethnicity, clinical disease stage, APOE4 genotypes, diagnosis of AD, baseline magnetic resonance imaging (MRI) findings consistent with a high risk of cerebral amyloid angiopathy (CAA), use of AD treatment, and use of concomitant antithrombotic medications at baseline.
Duration of Treatment
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment
Sponsors and contacts
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