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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

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: 27 Mar 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 Mar 2024 According to a BioArctic media release, the Oral Explanation scheduled for March 19 at the Committee for Medicinal Products for Human Use (CHMP) for lecanemab, which is currently under review by the European Medicines Agency (EMA), did not take place due to procedural reasons at EMA. The decision is entirely related to procedural reasons at EMA and is not related to the Marketing Authorisation Application (MAA) for lecanemab itself. The timing for the new meeting has not been determined yet.
    • 28 Feb 2024 According to a Biogen media release, the company will present the extension of efficacy results from Clarity AD at the 2024 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD™) from March 5-9 in Lisbon, Portugal, and virtually.
    • 11 Jan 2024 According to a Eisai Co Ltd Media Release, the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab, which is currently under review by the European Medicines Agency (EMA). The meeting of the SAG is expected to take place during the first quarter of 2024. Eisai expects the European Commission's decision for the MAA of lecanemab in the second quarter of 2024, if the opinion from the CHMP is received by March 31, 2024.
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