Recruiting

LEQEMBI

Sponsor:

Eisai Limited

Code:

NCT07762092

Conditions

Alzheimers Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

Brief summary:

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.

Conditions

Alzheimers Disease

Study ID

NCT07762092

Start date

Jul 30, 2026

Status verified date

Jul, 2026

Completion date

Apr 1, 2036

Anticipated

Primary completion date

Apr 1, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants Treated With LEQEMBI

Participants treated with LEQEMBI in Canada

Interventions

No Intervention

No intervention.

Primary outcome measure

  • Incidence and Severity of Known AEs [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Eisai Medical Information

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

Locations

Toronto Memory Program

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Eisai Limited

Last update posted

Sep 22, 2026

Last verified

Jul, 2026

Keywords

  • Alzheimer's Disease
  • Early Alzheimer's Disease
  • LEQEMBI
  • ARIA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Eisai Limited on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.