Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07781345

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Alzheimers Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Scottish Brain Sciences, Edinburgh, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention.

Primary outcomes

  1. Incidence and Severity of ARIA-E, ARIA-H, Intracerebral Hemorrhage >1 cm in Diameter and Anaphylaxis

    Time frame: Up to 3 years

Secondary outcomes

  1. Time to Progression to the Next Stage of Alzheimer's Disease (AD)

    Time frame: Up to 3 years

  2. Incidence and Severity of Serious Suspected Adverse Reactions and Adverse Reactions Leading to Discontinuation of LEQEMBI Treatment

    Time frame: Up to 3 years

  3. Drug Utilisation of LEQEMBI Based on Baseline Characteristics

    Time frame: 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.

  4. Duration of Treatment

    Time frame: Up to 3 years

    Drug Utilization of LEQEMBI will be assessed by Duration of Treatment

  5. Incidence of Serious ARIA and ICH

    Time frame: Up to 3 years

    Incidence of serious ARIA and ICH >1 cm in diameter will be assessed

  6. Effectiveness of Risk Minimization Measures

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eisai Medical Information

CONTACT

[email protected]

+1-888-274-2378

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Official study title

A Prospective Observational Registry Study to Evaluate the Use and Safety of LEQEMBI in Routine Clinical Practice

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.