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Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo

Mental Disorder Clinical Trial

Official title:
A 2-Month, Observational, Rollover Trial to Evaluate the Safety of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Were Previously Treated With Brexpiprazole (OPC 34712) or Placebo in a Phase 3, Double-blind Trial

Clinical Trial Summary

To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.

Clinical Trial Description

Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's disease and related dementias, and develop in the majority of dementia subjects. The presence of agitation in subjects with Alzheimer's disease places a significant burden not only on subjects and their caregivers but also on the healthcare system.

This is a trial designed to assess the ongoing safety of subjects with agitation associated with dementia of the Alzheimer's type after completing a 12-week double-blind trial of brexpiprazole or placebo; drug and placebo are discontinued prior to subjects enrolling in the safety follow-up trial. The trial consists of a continuous 2 month observation period. The trial population will include male and female subjects with a diagnosis of probable Alzheimer's disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02192554
Study type Observational
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Completed
Phase
Start date June 2014
Completion date May 2017
View Details
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