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
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|ClinicalTrials.gov Identifier: NCT02192554|
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : July 26, 2017
|Condition or disease|
|Agitation Associated With Alzheimer's Disease Alzheimer's Type Mental Disorder Nervous System Diseases|
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 Type :||Observational|
|Actual Enrollment :||450 participants|
|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|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
U.S. FDA Resources
- Adverse Events (AEs) [ Time Frame: Baseline to Month 2/Early Termination ]
- Mini-Mental State Examination (MMSE) score [ Time Frame: Baseline to Month 2/Early Termination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192554
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|Study Director:||Eva Kohegyi, MD, MS||Otsuka Pharmaceutical Development & Commercialization, Inc.|