Alzheimers Disease
Conditions
Keywords
Alzheimer's disease, LEQEMBI, ARIA
Brief summary
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.
Detailed description
This is a Post-Authorisation Safety Study registry designed to evaluate the safety, benefit-risk profile, drug utilisation, and effectiveness of risk minimisation measures of LEQEMBI in patients with AD in routine clinical practice The secondary purposes of the study are: * To describe the benefit-risk profile of LEQEMBI in routine clinical practice across patient subgroups as determined by progression to the next stage of AD (stratified by APOE4 genotype, concomitant antithrombotic therapy, and comorbid CAA). * To describe previously unknown AEs 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 drug utilisation of LEQEMBI and effectiveness of risk minimisation measures in routine clinical practice.
Interventions
OTHERNo Intervention
No intervention.
Sponsors
Eisai Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
-Participation or planning to participate in randomised controlled trials (RCTs) for mild cognitive impairment (MCI) or AD, and patients who have had prior exposure to anti-amyloid monoclonal antibody (mAb) treatment including prior use of lecanemab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and Severity of ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis | Up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression to the Next Stage of Alzheimer's Disease (AD) | Up to 3 years | — |
| Incidence and Severity of Serious Suspected Adverse Reactions and Adverse Reactions Leading to Discontinuation of LEQEMBI Treatment | Up to 3 years | — |
| Drug Utilisation of LEQEMBI Based on Baseline Characteristics | Up to 3 years | 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 | Up to 3 years | Drug Utilization of LEQEMBI will be assessed by Duration of Treatment |
| Incidence of Serious ARIA and ICH | Up to 3 years | Incidence of serious ARIA and ICH \>1 cm in diameter will be assessed |
| Effectiveness of Risk Minimization Measures | Up to 3 years | Percentage of participants with use of antithrombotic medications, demonstrating compliance with magnetic resonance imaging (MRI) monitoring schedule, demonstrating compliance with dose suspension or discontinuation, and, physician compliance with the Summary of Product Characteristics (SmPC) and provision of participant with the Patient Alert Card (PAC) and Patient Information Leaflet (PIL). |
Countries
United Kingdom
Contacts
CONTACTEisai Medical Information
Outcome results
None listed