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A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Trial Profile

A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

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

Latest Information Update: 18 Apr 2025

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At a glance

  • Drugs Lecanemab (Primary) ; Lecanemab (Primary)
  • Indications Alzheimer's disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Clarity AD
  • Sponsors Eisai Co Ltd; Eisai Inc

Most Recent Events

  • 15 Apr 2025 According to an Eisai Inc media release, the European Commission (EC) has granted the amyloid-beta monoclonal antibody Leqembi (lecanemab) Marketing Authorization (MA) in the European Union (EU).
  • 01 Apr 2025 According to a BioArctic AB media release, the European Commission (EC) has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Committee.
  • 25 Mar 2025 According to an Eisai Co Ltd Media Release, data from this trial will be presented at the American Academy of Neurology (AAN) Annual Meeting, being held in San Diego, California, and virtually from April 5-9.

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