Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01862640 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Alzheimers Disease and Nervous System Diseases, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
433
Enrollment target
20
Study locations

NCT01862640 is a Phase 3 study of Alzheimers Disease and Nervous System Diseases that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 433 participants, below the 4,058-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 5 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01862640, a Phase 3 study of Alzheimers Disease and Nervous System Diseases, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
433 participants
Enrollment target
20
Study locations

Study Summary

To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.

Conditions Studied

Alzheimers Disease Nervous System Diseases Mental Disorder Alzheimer's Type Agitation Associated With

Interventions

  • DRUG Placebo Oral Tablet
  • DRUG Brexpiprazole, OPC-34712

Study Locations (20)

Florida

  • - Coconut Creek
  • - Hialeah
  • - Hialeah
  • - Hialeah
  • - Lauderhill
  • - Miami
  • - Miami
  • - Miami
  • - Miami
  • - Miami
  • - Miami

California

  • - Bellflower
  • - Costa Mesa
  • - Downey
  • - Orange
  • - Redlands
  • - Yorba Linda

Alabama

  • - Tuscaloosa

Arizona

  • - Phoenix

Connecticut

  • - Norwalk

Trial Details

FieldValue
Enrollment Target 433 participants
Start Date 2013-07-11
Est. Completion 2017-03-15
Phase Phase 3

Sponsor

Otsuka Pharmaceutical Development & Commercialization

221 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01862640

The ClinicalTrials.gov registry entry for NCT01862640 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 433 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,058-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (89% lower). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.

NCT01862640 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT01862640 about?

NCT01862640 is a clinical study titled "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". To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.

What is the current status of trial NCT01862640?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 433 participants. The study started on 2013-07-11. Estimated completion is 2017-03-15.

What conditions does trial NCT01862640 study?

This clinical trial studies the following conditions: Alzheimers Disease, Nervous System Diseases, Mental Disorder, Alzheimer's Type, Agitation Associated With.

What interventions are being tested in trial NCT01862640?

The interventions under investigation include: Placebo Oral Tablet (DRUG), Brexpiprazole, OPC-34712 (DRUG).

Who is sponsoring clinical trial NCT01862640?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01862640 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Alzheimers Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Alzheimers Disease

All registered trials for this condition

Nervous System Diseases

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.