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

ClinicalTrials.gov ID: NCT01922258

Public ClinicalTrials.gov record NCT01922258. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 14, 2026, 10:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID: NCT01922258
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 270 participants

Conditions and interventions

Conditions

Interventions

Brexpiprazole, OPC-34712 Drug

Drug

Eligibility (public fields only)

Age range: 55 Years to 90 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2013
Primary completion: Feb 28, 2017
Completion: Feb 28, 2017
Last update posted: Nov 19, 2020

2013 – 2017

United States locations

U.S. sites: 28
U.S. states: 12
U.S. cities: 24

Facility	City	State	ZIP	Site status
Not listed	Imperial	California	92251	—
Not listed	Lakewood	California	08755	—
Not listed	Long Beach	California	90806	—
Not listed	Long Beach	California	90822	—
Not listed	Panorama City	California	91402	—
Not listed	Universal City	California	91950	—
Not listed	Denver	Colorado	80209	—
Not listed	Bradenton	Florida	34205	—
Not listed	Miami	Florida	33142	—
Not listed	Miami	Florida	33165	—
Not listed	Miami	Florida	33176	—
Not listed	Orange City	Florida	32763	—
Not listed	Atlanta	Georgia	30331	—
Not listed	Smyrna	Georgia	30080	—
Not listed	Honolulu	Hawaii	96817	—
Not listed	Indianapolis	Indiana	46256	—
Not listed	Quincy	Massachusetts	02169	—
Not listed	South Dartmouth	Massachusetts	02747	—
Not listed	Ann Arbor	Michigan	48105	—
Not listed	Brooklyn	New York	11214	—
Not listed	Buffalo	New York	14215	—
Not listed	New Hyde Park	New York	11040	—
Not listed	Charlotte	North Carolina	28270	—
Not listed	Raleigh	North Carolina	27609	—
Not listed	Austin	Texas	78757	—
Not listed	Dallas	Texas	75231	—
Not listed	Dallas	Texas	75243	—
Not listed	Woodstock	Vermont	05091	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01922258, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 19, 2020 · Synced May 14, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01922258 live on ClinicalTrials.gov.

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