NCT01922258

Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

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: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

Detailed description

Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's disease and related dementias and develop in the majority of dementia subjects. The presence of agitation in subjects with Alzheimer's disease places a significant burden not only on subjects and their caregivers but also on the healthcare system. This is a trial designed to assess the safety and efficacy of flexible dosing of brexpiprazole in the treatment of subjects with agitation associated with dementia of the Alzheimer's type. The trial consists of a 12-week double-blind treatment period with a 30-day follow-up. The trial population will include male and female subjects between 55 and 90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are residing either in an institutionalized setting or in a non-institutionalized setting where the subject is not living alone.

Conditions

• Agitation Associated With
• Alzheimer's Disease
• Alzheimer's Type
• Mental Disorder
• Nervous System Diseases

Interventions

Type	Name	Description
DRUG	Brexpiprazole, OPC-34712	Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2013-08-14
• Last updated: 2020-11-20
• Results posted: 2020-07-07

Locations

70 sites across 9 countries: United States, Bulgaria, Canada, Finland, France, Russia, Slovenia, Ukraine, United Kingdom