Trial Profile
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing 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
Price :
$35
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At a glance
- Drugs Brexpiprazole (Primary)
- Indications Agitation; Alzheimer's disease
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 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.
- 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.
- 01 Dec 2022 According to an Otsuka Pharmaceutical Media Release, results from this trial were presented at the Clinical Trials for Alzheimer's Disease (CTAD) Congress 2022.