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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: 11 Jul 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

  • 03 Jul 2025 Planned End Date changed from 15 Sep 2027 to 26 May 2027.
  • 03 Jul 2025 Planned primary completion date changed from 15 Sep 2027 to 26 May 2027.
  • 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).

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