Last updated on April 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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ATP Clinical Research Inc.

Costa Mesa, CA United States
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MD First Research, LLC

Chandler, AZ United States
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Global Clinical Trials

Costa Mesa, CA United States
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Shreenath Clinical Services

Lakewood, CA United States
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Los Angeles, CA United States
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Califnoria Neurological Services

Panorama City, CA United States
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SC3 Research

Pasadena, CA United States
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Nova Clinical Research

Bradenton, FL United States
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Advanced Clinical Research

Coral Gables, FL United States
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Arocha Research Center

Coral Gables, FL United States
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ICR Sites, LLC

Doral, FL United States
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Research in Miami Inc.

Hialeah, FL United States
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Galiz Research

Hialeah, FL United States
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MaxBlue Institute

Hialeah, FL United States
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SIH Research

Kissimmee, FL United States
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Ocean Blue Medical Research

Miami Springs, FL United States
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IMIC Inc.

Palmetto Bay, FL United States
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Clinovation Research, LLC

Weston, FL United States
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Alzheimer Disease Center

Winchester, MA United States
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Precise Research Centers

Flowood, MS United States
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Arch Clinical Trials

Saint Louis, MO United States
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Bio Behavioral Health

Toms River, NJ United States
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Gadolin Research, LLC

Beaumont, TX United States
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Centex Studies Inc.

Houston, TX United States
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Bio Pharma Informatic Inc.

Houston, TX United States
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Northpointe Psychiatry

Lewisville, TX United States
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Recruitment Status: Open


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