Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Last updated: May 9, 2024
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Dementia

Williams Syndrome

Manic Disorders

Treatment

Brexpiprazole

Clinical Study ID

NCT03724942
331-102-00184
JapicCTI-184179
  • Ages 55-89
  • All Genders

Study Summary

To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who completed the double-blind treatment period for 10 weeks and allobservation, examination and evaluation at Week 10 of the double-blind trial.

  • Patients whose caregiver can properly collect the necessary information.

Exclusion

Exclusion Criteria:

  • Patients who had a serious adverse event which the principal investigator orsub-investigator assessed as related to the investigator product during thedouble-blind trial.

  • Patients who had delirium during the double-blind trial.

Study Design

Total Participants: 164
Treatment Group(s): 1
Primary Treatment: Brexpiprazole
Phase: 3
Study Start date:
November 09, 2018
Estimated Completion Date:
January 05, 2022

Connect with a study center

  • Jisenkai Nanko Psychiatric Institute

    Shirakawa,
    Japan

    Site Not Available

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