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A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

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Trial Profile

A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Aug 2024

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At a glance

  • Drugs Bupropion/dextromethorphan (Primary)
  • Indications Agitation; Alzheimer's disease; Dementia
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ACCORD-2
  • Sponsors Axsome Therapeutics

    • Most Recent Events

    • 05 Aug 2024 According to an Axsome Therapeutics media release, topline results of ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimer's disease agitation anticipated 2H 2024 and target enrollment reached.
    • 06 May 2024 According to an Axsome Therapeutics media release, this ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimers disease agitation is initiated and the enrollment completion anticipated mid-year 2024.
    • 29 Mar 2024 Protocol of study has been amended to add trial design part of double blind and parallel segment , number of arms has been increased form 1 to 3. Planned patients number increased to 300 from 260, primary endpoint Time to relapse of agitation symptoms has been added

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