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
Sponsor study identifier
interventional
410
1 country
1
Study Start
August 20, 2018
Actual (reported)Primary Completion
April 21, 2023
Actual (reported)Study Completion
May 15, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 15, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2018
Actual (reported)August 8, 2018
Actual (reported)August 20, 2018
Actual (reported)April 21, 2023
Actual (reported)May 15, 2023
Actual (reported)November 14, 2024
Actual (reported)Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.
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
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.
Baseline and 10 weeks first dose, on average 10 weeks
Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.
Baseline and 10 weeks first dose, on average 10 weeks
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
Drug: 1 tablet /day Once daily for 10 weeks
Placebo: 1 tablet /day Once daily for 10 weeks
Jisenkai Nanko Psychiatric Institute
Shirakawa, Japan
Nakamura Y, Seiyama Y, Shimizu K, Shibasaki Y, Toda R, Nakamichi N, Adachi J, Hirota N, Nakai M, Takahashi K. Impact of dementia severity on efficacy of brexpiprazole for agitation in Alzheimer's dementia: A post hoc analysis of a randomized, double-blind, placebo-controlled study in Japan. J Alzheimers Dis. 2026 Oct 8:13872877261493010. doi: 10.1177/13872877261493010. Online ahead of print.
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.
410 participants (actual enrollment reported by the registry).
First Submitted
August 5, 2018
First Posted
August 8, 2018
Study Start
August 20, 2018
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 21, 2023
Actual (reported)Study Completion
May 15, 2023
Actual (reported)Last Updated
November 14, 2024
Results First Posted
November 14, 2024
Record last verified: 2024-04
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.
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Source: ClinicalTrials.gov.
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