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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Agitation Associated With Dementia of the Alzheimer's Type

Intervention / Treatment
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* Drug: Brexpiprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Cohen-Manfield Agitation Incentory(CMAI) score at 10 weeks |  | Baseline, 10 weeks after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in CMAI score at 10 weeks |  | Baseline, 10 weeks after dosing | 
| Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 10 weeks |  | Baseline, 10 weeks after dosing |