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

ConditionAlzheimers Disease

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorEisai Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Participants with early Alzheimer's Disease treated with lecanemab will be observed retrospectively.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

No Intervention
Other intervention
This is a non-interventional study.

Treatment groups

270 Participants

are divided into 1 treatment group

Group A: Participants Treated With Lecanemab1 intervention

Trial outcomes

Primary outcomes

Change from Baseline in the CDR-SB

Time frame

Baseline, 18 months

Secondary outcomes

Time to Progression to the Next Stage of Alzheimer's Disease as Assessed by Global CDR Score

Time frame

Baseline, 18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eisai Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: