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

September 12, 2024 updated by: Otsuka Pharmaceutical Co., Ltd.

A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

410

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Shirakawa, Japan
        • Jisenkai Nanko Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)

Exclusion Criteria:

  • Patients who have dementia other than dementia of the Alzheimer's type
  • Patients diagnosed with delirium between 30 days before the screening examination and 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brexpiprazole, 1mg/day
Drug: 1mg/day Once daily for 10 weeks
Drug: Brexpiprazole
Drug: 1 tablet /day Once daily for 10 weeks
Experimental: Brexpiprazole, 2mg/day
Drug: 2mg/day Once daily for 10 weeks
Drug: Brexpiprazole
Drug: 1 tablet /day Once daily for 10 weeks
Placebo Comparator: Placebo
Drug: Placebo (0mg/day) Once daily for 10 weeks
Drug: Placebo
Placebo: 1 tablet /day Once daily for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.
Time Frame: Baseline and 10 weeks first dose, on average 10 weeks
The CMAI assessed the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consisted of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score was 29, and the maximum possible CMAI total score was 203. A decrease in score indicated improvement in symptoms.
Baseline and 10 weeks first dose, on average 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.
Time Frame: Baseline and 10 weeks first dose, on average 10 weeks
The CGI-S was used to rate the severity of agitation. Scores were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A decrease in score indicated improvement in symptoms.
Baseline and 10 weeks first dose, on average 10 weeks
Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.
Time Frame: Baseline and 10 weeks first dose, on average 10 weeks
The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.
Baseline and 10 weeks first dose, on average 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2018

Primary Completion (Actual)

April 21, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

August 5, 2018

First Submitted That Met QC Criteria

August 5, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 331-102-00088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Agitation Associated With Dementia of the Alzheimer's Type

Clinical Trials on Brexpiprazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe