For Healthcare Professionals

A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease

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About the study

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy and to explore the dose response of lecanemab using a composite clinical score (ADCOMS). BAN2401-G000-201 Core study is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. Any participant who completes the study treatment (Visit 42 [Week 79] of the Core study) or discontinues the Core Study will be eligible to participate in the Extension Phase, provided they meet the Extension Phase inclusion and exclusion criteria. Participants will receive 10 mg/kg biweekly for up to 60 months or until the drug is commercially available in the country, where the subject resides, or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. The Follow-up Visit in the Extension Phase will take place 3 months after the last dose of study drug. TEST
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

(Core Study) for Mild Cognitive Impairment due to Alzheimer's Disease

  1. Intermediate likelihood:
  2. Subjects who meet the National Institute of Aging
  3. Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment due to Alzheimer's disease
  4. intermediate likelihood
  5. Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
  6. Subjects who report a history of subjective memory decline with gradual onset and slow progression over the last one year before Screening; MUST be corroborated by an informant Key

EXCLUSION CRITERIA

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    Study Locations

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    How to Apply


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    Study’s details


    Contition

    Alzheimer's Disease

    Age (in years)

    50 - 90

    Phase

    Phase 2

    Participants needed

    856

    Est. Completion Date

    Feb 2025

    Treatment type

    Interventional


    Sponsor

    Eisai Inc.

    ClinicalTrials.gov identifier

    NCT01767311

    Study number

    BAN2401-G000-201

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