Last updated on July 2019

A Trial to Evaluate the Safety Efficacy and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

Brief description of study

This study compares the efficacy of 2 doses of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type.

Detailed Study Description

This is a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the efficacy, safety, and tolerability of brexpiprazole compared with placebo. 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. This trial will analyze data gathered from 225 subjects at multiple countries. Subjects may also be eligible to enter an active extension trial, following completion of this trial.

Clinical Study Identifier: NCT03548584

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Health Care Family Research 2

Pembroke Pines, FL United States
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Clinovation Research, LLC

Weston, FL United States
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