Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07781345

A Postmarketing Study of LEQEMBI in United Kingdom (UK) Participants With Alzheimer's Disease (AD)

Conditions: Alzheimers Disease

Sex: All
Healthy volunteers: No
Enrollment: 400
Sponsor: Eisai Limited

Location: Scottish Brain Sciences Edinburgh

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07781345). StuddyBuddy aggregates publicly available trial information.