NCT02192554

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Agitation Associated With Alzheimer's Disease
• Alzheimer's Type
• Mental Disorder
• Nervous System Diseases

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-07-17
• Last updated: 2018-04-30

Locations

84 sites across 12 countries: United States, Bulgaria, Canada, Croatia, France, Germany, Russia, Serbia, Slovenia, Spain, Ukraine, United Kingdom