NCT07864623Not yet recruiting
A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 270 (estimated)
- First submitted
- 2 Oct 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Eisai Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT07864623
What you commit to
- Study type: Observational
- Planned participants: 270
- From 30 Oct 2026 to the primary completion date, 31 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any other anti-amyloid treatment prior to and during the 18-month LEQEMBI treatment period
Other illness
- Conditions highlighted under "Contraindications" section in the Canadian Product Monograph
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Nutley | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.