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Clinical Trials in the UK / NCT07781345
Starting soon Observational

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

NCT07781345 · tracked via the Priya Life Science UK tracker
Sponsor
Eisai Limited
Phase
Observational
Started
2026-08-31
Last updated
2026-08-24

Condition(s) studied

Alzheimers Disease

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: No intervention.

Study 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

Sex
ALL
Min age
—
Max age
—
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.

Primary outcome measure(s)

  • Incidence and Severity of ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis — Up to 3 years

Trial sites (3)

FacilityCityRegionStatus
Scottish Brain Sciences Edinburgh United Kingdom
Recognition Health Limited London United Kingdom
Neuroclnx Motherwell United Kingdom

Other trials for the same condition

Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease Active, not recruiting
A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease Active, not recruiting
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07781345 on ClinicalTrials.gov ↗ ← All trials in the UK