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

NCT07781345 | Not Yet Recruiting FDA Drug

• 1 other identifier: BAN2401-E044-504
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Alzheimers Disease

Keywords

Alzheimer's disease; LEQEMBI; ARIA

Outcome Measures

Primary Outcomes (1)

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

  Up to 3 years

Secondary Outcomes (6)

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

  Up to 3 years

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

  Up to 3 years

• Drug Utilisation of LEQEMBI Based on Baseline Characteristics

  Up to 3 years

• Duration of Treatment

  Up to 3 years

• Incidence of Serious ARIA and ICH

  Up to 3 years

Study Arms (1)

Participants Treated With LEQEMBI

Other: No Intervention

Interventions

No Intervention OTHER

No intervention.

Participants Treated With LEQEMBI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with AD who are prescribed LEQEMBI by a physician in routine clinical practice in the UK.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (3)

Scottish Brain Sciences

Edinburgh, EH12 5PJ, United Kingdom

Location

Recognition Health Limited

London, W1G 8TA, United Kingdom

Location

Neuroclnx

Motherwell, ML1 4UF, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Eisai Medical Information

CONTACT

+1-888-274-2378; esi_medinfo@eisai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 24, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (3)