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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01862640

Public ClinicalTrials.gov record NCT01862640. 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.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 2:46 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 2 Fixed Doses of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Study identification

NCT ID
NCT01862640
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
433 participants

Conditions and interventions

Interventions

  • Brexpiprazole, OPC-34712 Drug
  • Placebo Oral Tablet 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
Jul 10, 2013
Primary completion
Mar 14, 2017
Completion
Mar 14, 2017
Last update posted
Dec 30, 2020

2013 – 2017

United States locations

U.S. sites
37
U.S. states
15
U.S. cities
28
Facility City State ZIP Site status
Not listed Tuscaloosa Alabama 35404
Not listed Phoenix Arizona 85013
Not listed Bellflower California 90706
Not listed Costa Mesa California 92627
Not listed Downey California 90706
Not listed Orange California 92868
Not listed Redlands California 92373
Not listed Yorba Linda California 92886
Not listed Norwalk Connecticut 06851
Not listed Coconut Creek Florida 33024
Not listed Hialeah Florida 33012
Not listed Hialeah Florida 33013
Not listed Hialeah Florida 33018
Not listed Lauderhill Florida 33319
Not listed Miami Florida 33122
Not listed Miami Florida 33126
Not listed Miami Florida 33136
Not listed Miami Florida 33137
Not listed Miami Florida 33145
Not listed Miami Florida 33161
Not listed Miami Florida 33174
Not listed Miami Springs Florida 33166
Not listed Sarasota Florida 34239
Not listed Decatur Georgia 30033
Not listed Suwanee Georgia 30024
Not listed Weymouth Massachusetts 02190
Not listed St Louis Missouri 63128
Not listed St Louis Missouri 63141
Not listed Las Vegas Nevada 89148
Not listed Mount Arlington New Jersey 07856
Not listed Paterson New Jersey 08759
Not listed Toms River New Jersey 08755
Not listed Hickory North Carolina 28601
Not listed Oklahoma City Oklahoma 73118
Not listed Franklin Tennessee 37064
Not listed Bedford Texas 76022
Not listed Waukesha Wisconsin 53188

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 48 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01862640, 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 Dec 30, 2020 · Synced Jul 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01862640 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →