A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease

NCT07864623 — Not yet recruiting, 270 participants, Eisai Inc.

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A Postmarketing Study to Confirm Treatment Benefit and Fulfill Conditions Associated With Market Authorization in Canada for LEQEMBI (Lecanemab) Administered in Adult Patients With a Clinical Diagnosis of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease (Early Alzheimer's Disease), Who Are Apolipoprotein Epsilon 4 (ApoE Epsilon 4) Noncarriers or Heterozygous Carriers With Confirmed Amyloid Pathology

Registry	NCT07864623
Status	Not yet recruiting
Study type	Observational
Enrollment	270 (Estimated)
Sponsor	Eisai Inc. (Industry)
Conditions	Alzheimers Disease
Interventions	No Intervention (Other)
Dates	start 2026-10-30 (estimated), primary completion 2029-08-31 (estimated), completion 2029-08-31 (estimated), first posted 2026-10-08, last updated 2026-10-08
Locations	1 site in United States

-Summary

The primary purpose of this study is to evaluate the efficacy of LEQEMBI in participants with early Alzheimer's disease (AD) indicated per Canada Product Monograph (APOE4 non-carriers and heterozygotes; indicated population) compared with placebo (PBO)-treated participants from BAN2401-G000-301 (Study 301) Core study on change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment.

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+Detailed description

This is a non-interventional study using real-world retrospective efficacy (CDR-SB) data from prescribing institutions in North America to evaluate the efficacy of LEQEMBI.

As this is a Retrospective Database Study, the Study Start Date for this study references the date at which the first set of data will become available.

+Arms and interventions

Arm	Type	Interventions	Description
Participants Treated With Lecanemab		Other: No Intervention

No Intervention (Other): This is a non-interventional study.

+Outcome measures

Primary outcomes

Change from Baseline in the CDR-SB [Baseline, 18 months]

Secondary outcomes

Time to Progression to the Next Stage of Alzheimer's Disease as Assessed by Global CDR Score [Baseline, 18 months]

+Eligibility

Sex: All

Inclusion Criteria:

* Participant (or legally authorized representative) has provided written informed consent to participate in the local site registry
* Mild cognitive impairment (MCI) due to AD or mild AD dementia, according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
* Global CDR at baseline of 0.5 or 1
* APOE4 heterozygous or noncarrier
* Have had a baseline CDR-SB (before initiation of LEQEMBI treatment)
* Completed 18 months of LEQEMBI treatment, with an 18-month CDR-SB assessment

Exclusion Criteria:

* Use of any other anti-amyloid treatment prior to and during the 18-month LEQEMBI treatment period
* Conditions highlighted under "Contraindications" section in the Canadian Product Monograph

+Locations (1)

Facility	City	Country	Status
Eisai Trial Site #1	Nutley, New Jersey	United States