Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Brexpiprazole
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Drug: Brexpiprazole
Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks
Other Names:
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Outcome Measures
Primary Outcome Measures
- The frequency of Adverse events [From baseline to week 14]
Secondary Outcome Measures
- Mean change from baseline in Cohen-Mansfield Agitation Inventory (CMAI) score at 14 weeks after dosing [Baseline and 14 weeks after dosing]
- Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 14 weeks after dosing [Baseline and 14 weeks after dosing]
- Mean change from baseline in Clinical Global Impression of Improvement (CGI-I) score at 14 weeks after dosing [Baseline and 14 weeks after dosing]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
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Patients whose caregiver can properly collect the necessary information.
Exclusion Criteria:
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Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
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Patients who had delirium during the double-blind trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Jisenkai Nanko Psychiatric Institute | Shirakawa | Japan |
Sponsors and Collaborators
- Otsuka Pharmaceutical Co., Ltd.
Investigators
- Study Director: Osamu Sato, Otsuka Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 331-102-00184
- JapicCTI-184179