Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
NCT ID: NCT03620981
Last Updated: 2024-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
410 participants
INTERVENTIONAL
2018-08-20
2023-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Brexpiprazole, 1mg/day
Drug: 1mg/day Once daily for 10 weeks
Brexpiprazole
Drug: 1 tablet /day Once daily for 10 weeks
Brexpiprazole, 2mg/day
Drug: 2mg/day Once daily for 10 weeks
Brexpiprazole
Drug: 1 tablet /day Once daily for 10 weeks
Placebo
Drug: Placebo (0mg/day) Once daily for 10 weeks
Placebo
Placebo: 1 tablet /day Once daily for 10 weeks
Interventions
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Brexpiprazole
Drug: 1 tablet /day Once daily for 10 weeks
Placebo
Placebo: 1 tablet /day Once daily for 10 weeks
Eligibility Criteria
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Inclusion 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 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
55 Years
90 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Jisenkai Nanko Psychiatric Institute
Shirakawa, , Japan
Countries
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References
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Nakamura Y, Adachi J, Hirota N, Iba K, Sasajima C, Shimizu K, Nakai M, Takahashi K. Brexpiprazole's impacts on patients and caregivers in agitation in Alzheimer's dementia. Alzheimers Dement. 2025 Jul;21(7):e70522. doi: 10.1002/alz.70522.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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331-102-00088
Identifier Type: -
Identifier Source: org_study_id
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