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

Agitation Associated With Dementia of the Alzheimer's Type Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620981
• Other study ID #: 331-102-00088
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 20, 2018
• Est. completion date: May 15, 2023

Study information

• Verified date: May 2023
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: May 15, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation Associated With Dementia of the Alzheimer's Type
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

Intervention

Drug:
• Brexpiprazole
Drug: 1 tablet /day Once daily for 10 weeks
• Placebo
Placebo: 1 tablet /day Once daily for 10 weeks

Locations

Country	Name	City	State
Japan	Jisenkai Nanko Psychiatric Institute	Shirakawa

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in Cohen-Manfield Agitation Incentory(CMAI) score at 10 weeks		Baseline, 10 weeks after dosing
Secondary	Mean change from baseline in CMAI score at 10 weeks		Baseline, 10 weeks after dosing
Secondary	Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 10 weeks		Baseline, 10 weeks after dosing