NCT03724942

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 55 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Agitation Associated With Dementia of the Alzheimer's Type

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks

Timeline

• Start date: 2018-11-09
• Primary completion: 2021-12-02
• Completion: 2022-01-05
• First posted: 2018-10-30
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: Japan