NCT01862640

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 in the Treatment of Alzheimer's Agitation

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: Phase 3
• Study type: Interventional
• Enrollment: 433 (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 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.

Detailed description

Behavioral symptoms, such as agitation, are core features in participants with Alzheimer's disease and related dementias and develop in the majority of dementia participants. The presence of agitation in participants with Alzheimer's disease places a significant burden not only on participants and their caregivers but also on the healthcare system. This is a trial designed to assess the safety and efficacy of brexpiprazole in the treatment of participants with agitation associated with dementia of the Alzheimer's Type. The trial consists of a continuous 12-week double-blind treatment period with a 30-day follow-up. The trial population will include male and female participants 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 participant 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	Once-daily, tablets
DRUG	Placebo Oral Tablet	Once-daily, tablets

Timeline

• Start date: 2013-07-11
• Primary completion: 2017-03-15
• Completion: 2017-03-15
• First posted: 2013-05-24
• Last updated: 2020-12-31
• Results posted: 2020-06-16

Locations

85 sites across 7 countries: United States, Croatia, Germany, Russia, Serbia, Spain, Ukraine