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

Last updated: September 12, 2024
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

2/3

Condition

Manic Disorders

Dementia

Williams Syndrome

Treatment

Placebo

Brexpiprazole

Clinical Study ID

NCT03620981
331-102-00088
  • Ages 55-90
  • All Genders

Study Summary

To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who satisfy both of the following diagnostic criteria:

  1. Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.

  2. Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA.

  • Hospitalized patients or care facility patients or care at home patients

  • Patients with an MMSE score of 1 to 22

  • Patients who have the agitation defined according to the "Consensus provisionaldefinition of agitation in cognitive disorders" from the InternationalPsychogeriatric Association (IPA)

Exclusion

Exclusion Criteria:

  • Patients who have dementia other than dementia of the Alzheimer's type

  • Patients diagnosed with delirium between 30 days before the screening examinationand baseline evaluation according to DSM-5.

  • Patients diagnosed with any of the following disorders according to DSM-5:

  • Schizophrenia spectrum and other psychotic disorders

  • Bipolar and related disorders

  • Major depressive disorder

Study Design

Total Participants: 410
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
August 20, 2018
Estimated Completion Date:
May 15, 2023

Connect with a study center

  • Jisenkai Nanko Psychiatric Institute

    Shirakawa,
    Japan

    Site Not Available

  • Yoyogi Mental Clinic

    Tokyo,
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.