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A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole (OPC-34712) in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer's Type

Trial Profile

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole (OPC-34712) in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer's Type

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Mar 2024

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At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Agitation; Alzheimer's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 20 Mar 2024 Results comparing IGC AD1 Phase 2 Interim 6 week results (NCT05543681) with existing Brexpiprazole Phase 3 Results from NCT03548584, NCT01862640 and NCT01922258, presented in an IGC Pharma media release.
    • 18 Mar 2024 According to an Otsuka Pharmaceutical media release, new data analyses on the efficacy of brexpiprazole for agitation associated with dementia due to alzheimer's disease of two pivotal studies were presented on March 16 at the American Association for Geriatric Psychiatry (AAGP) 2024 Annual Meeting in Atlanta.
    • 24 Jan 2024 According to an Otsuka Pharmaceutical media release, Health Canada has issued a Notice of Compliance for REXULTI (brexpiprazole) for use in the symptomatic management of agitation associated with Alzheimer's dementia (AAD) in patients with aggressive behaviour, unresponsive to non-pharmacological approaches.
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