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
Eisai Inc.
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.
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- OtherNo Intervention
This is a non-interventional study.
Location
- Eisai Trial Site #1Nutley, New Jersey