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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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Trial Profile

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: 23 Aug 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

    • 22 Aug 2024 According to a BioArctic media release, based on results form this trial the has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.
    • 14 Aug 2024 According to a BioArctic media release, based on results form this trial the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer's disease (AD).
    • 30 Jul 2024 According to a BioArctic media release,were presented at the Alzheimers Association International Conference (AAIC) 2024, held in Philadelphia, USA, and virtually as well as presentation slides for the two scientific sessions on lecanemab at the AAIC will be available on the Eisai Co. Ltd. Investor Page by 7:00 p.m. on July 30th EDT.

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