NCT07781345 · NOT YET RECRUITING
A Postmarketing Study of LEQEMBI in United Kingdom (UK) Participants With Alzheimer's Disease (AD)
This is a postmarketing safety study — not a clinical trial testing whether Leqembi works, but an observational study tracking side effects in UK patients already prescribed it in routine care. Researchers are watching for serious adverse events, especially ARIA (brain swelling and microbleeds), large brain hemorrhages, and severe allergic reactions. There is no phase designation because no experimental treatment is being given.
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-24