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

Primary Purpose

Agitation Associated With Dementia of the Alzheimer's Type

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Brexpiprazole
Placebo
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation Associated With Dementia of the Alzheimer's Type

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jisenkai Nanko Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Brexpiprazole, 1mg/day

Brexpiprazole, 2mg/day

Placebo

Arm Description

Drug: 1mg/day Once daily for 10 weeks

Drug: 2mg/day Once daily for 10 weeks

Drug: Placebo (0mg/day) Once daily for 10 weeks

Outcomes

Primary Outcome Measures

Mean change from baseline in Cohen-Manfield Agitation Incentory(CMAI) score at 10 weeks

Secondary Outcome Measures

Mean change from baseline in CMAI score at 10 weeks
Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 10 weeks

Full Information

First Posted
August 5, 2018
Last Updated
May 23, 2023
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03620981
Brief Title
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
April 21, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation Associated With Dementia of the Alzheimer's Type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brexpiprazole, 1mg/day
Arm Type
Experimental
Arm Description
Drug: 1mg/day Once daily for 10 weeks
Arm Title
Brexpiprazole, 2mg/day
Arm Type
Experimental
Arm Description
Drug: 2mg/day Once daily for 10 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo (0mg/day) Once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
Drug: 1 tablet /day Once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: 1 tablet /day Once daily for 10 weeks
Primary Outcome Measure Information:
Title
Mean change from baseline in Cohen-Manfield Agitation Incentory(CMAI) score at 10 weeks
Time Frame
Baseline, 10 weeks after dosing
Secondary Outcome Measure Information:
Title
Mean change from baseline in CMAI score at 10 weeks
Time Frame
Baseline, 10 weeks after dosing
Title
Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 10 weeks
Time Frame
Baseline, 10 weeks after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who satisfy both of the following diagnostic criteria: Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5. 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
Facility Information:
Facility Name
Jisenkai Nanko Psychiatric Institute
City
Shirakawa
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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