A Post Authorization Registry Study of Participants Treated With LEQEMBI

August 12, 2026 updated by: Eisai Limited

Post Authorization Registry Study of Patients Treated With LEQEMBI

To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy [CAA]).

The secondary purpose of this study is,

To describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.

To describe previously unknown adverse events related to the long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment (regardless of causality).

To describe drug utilization of LEQEMBI and to assess the effectiveness of risk minimization measures in routine clinical practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a noninterventional, prospective, observational Patient Registry study that will be conducted in Canada, the main purpose of which is to describe the incidence and severity of known adverse events in participants treated with LEQEMBI during routine clinical practice.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia - CARD
      • Victoria, British Columbia, Canada
        • UBC Victoria - Neil and Susan Manning Cognitive Health Initiative
    • Ontario
      • London, Ontario, Canada
        • Parkwood Hospital - London
      • Mississauga, Ontario, Canada
        • Trillium Hospital
      • Ottawa, Ontario, Canada
        • Bruyère Institute
      • Peterborough, Ontario, Canada
        • Kawartha Center
      • Toronto, Ontario, Canada
        • Toronto Memory Program
      • Toronto, Ontario, Canada
        • Toronto Western Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University, Douglas Mental Health
      • Québec, Quebec, Canada
        • CHU de Québec-Université Laval Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population comprises of participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada and are enrolled into the Patient Registry.

Description

Inclusion Criteria:

  • Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants Treated With LEQEMBI
Participants treated with LEQEMBI in Canada
Other: No Intervention
No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Known AEs
Time Frame: Up to 3 years
Incidence and severity of known AEs will be reported. AEs will include ARIA-E and ARIA-H (including asymptomatic and symptomatic) and ICH >1 cm in diameter in participants treated with LEQEMBI.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Progression to the Next Stage of Alzheimer's Disease
Time Frame: Up to 3 years
Up to 3 years
Incidence and Severity of Previously Unknown Adverse Events Related to the Long-Term Safety of LEQEMBI in Routine Clinical Practice
Time Frame: Up to 3 years
Incidence and severity of serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment.
Up to 3 years
Drug Utilization of LEQEMBI
Time Frame: Up to 3 years
Drug utilization will be assessed by count (n) and proportion (%) of age, ethnicity, sex, residential location, APOE4 genotype, AD diagnosis, baseline MRI findings, baseline antithrombotic use, participants prescribed LEQEMBI according to PM, and treatment discontinuation by reason.
Up to 3 years
Duration of Treatment
Time Frame: Up to 3 years
Drug Utilization of LEQEMBI will be assessed by Duration of Treatment
Up to 3 years
Effectiveness of Risk Minimization Measures
Time Frame: Up to 3 years
Effectiveness of Risk Minimization Measures will be assessed by the proportion of participants using antithrombotic medications during treatment, demonstrating compliance with MRI monitoring (before the 3rd, 5th, 7th, and 14th infusions), with dose suspension or discontinuation of LEQEMBI for ARIA or ICH >1 cm, and reporting physician compliance with providing educational materials at treatment initiation and after safety updates (if applicable), including type of materials, distribution method, and quantity.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

April 1, 2036

Study Completion (Estimated)

April 1, 2036

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

August 12, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAN2401-A001-506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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