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

NCT07781345

Not Yet RecruitingN/A

Sponsor: Eisai Limited

Conditions: Alzheimers Disease

Interventions: No Intervention

Countries: United Kingdom

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 overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (3)
  • Edinburgh, United Kingdom
  • London, United Kingdom
  • Motherwell, United Kingdom