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A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

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A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 09 Dec 2024

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At a glance

  • Drugs Lecanemab (Primary)
  • Indications Alzheimer's disease; Dementia; Mild cognitive impairment
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms CLARITY-AD
  • Sponsors Biogen; Eisai Co Ltd; Eisai Inc

    • Most Recent Events

    • 04 Dec 2024 According to a Eisai Co Ltd Media Release, based on results from this trial, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved LEQEMBI (lecanemab) for the treatment of early Alzheimer's disease (AD).
    • 04 Dec 2024 According to a BioArctic media release, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for the treatment of early Alzheimer's disease, based on the data from this trial.
    • 14 Nov 2024 According to a Eisai Co Ltd Media Release, a positive opinion has been received from the CHMP of the EMA recommending approval of lecanemab as a treatment of adult patients with mild dementia due to Alzheimer's disease. Final decision from the European Commission is expected within 67 days of receipt of CHMP opinion.

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