Last updated on October 2018

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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Rozina Jadoon

ATP Clinical Research Inc.
Costa Mesa, CA United States
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Neurology Center of North Orange County
Fullerton, CA United States
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Arocha Research Center
Coral Gables, 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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Premier Clinical Research
Miami, FL United States
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Richard H. Weisler, MD PA Associates
Raleigh, NC United States
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MD First Research, LLC
Chandler, AZ United States
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Territory Neurology & Research Institute
Tucson, 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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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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Allied Biomedical Research Institute
Miami, FL United States
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IMIC Inc.
Palmetto Bay, FL United States
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University of West Florida (UWF) Clinical Trials
Pensacola, FL United States
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Clinovation Research, LLC
Weston, FL United States
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Georgia Neurology and Sleep Medicine Associates
Suwanee, GA United States
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Alzheimer Disease Center
Winchester, MA United States
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Michigan Clinical Research Institute PC
Ann Arbor, MI 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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Lehigh Center for Clinical Research
Allentown, PA 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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