Brexpiprazole for the Long-term 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 Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724942
• Other study ID #: 331-102-00184
• Secondary ID: JapicCTI-184179
• Status: Completed
• Phase: Phase 3
• Start date: November 9, 2018
• Est. completion date: January 5, 2022

Study information

• Verified date: January 2022
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 5, 2022
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 89 Years

Eligibility

Inclusion Criteria:

• 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.

• Patients whose caregiver can properly collect the necessary information.

Exclusion Criteria:

• 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.

• Patients who had delirium during the double-blind trial.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Brexpiprazole
Brexpiprazole 1mg or 2mg will be orally once daily for 14 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	The frequency of Adverse events		From baseline to week 14
Secondary	Mean change from baseline in Cohen-Mansfield Agitation Inventory (CMAI) score at 14 weeks after dosing		Baseline and 14 weeks after dosing
Secondary	Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 14 weeks after dosing		Baseline and 14 weeks after dosing
Secondary	Mean change from baseline in Clinical Global Impression of Improvement (CGI-I) score at 14 weeks after dosing		Baseline and 14 weeks after dosing