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



Status:Completed
Conditions:Alzheimer Disease, Neurology, Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:5/2/2018
Start Date:June 2014
End Date:May 2017

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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

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

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.

Inclusion Criteria:

- The investigator must assess the capacity of the subject to provide informed consent
prior to enrollment and throughout the trial.

- Male and female subjects who completed both the 12-week double-blind treatment period
and the 30-day safety follow-up visit of the previous brexpiprazole trial.

- Subject has an identified caregiver who is usually assigned to care for the subject on
a regular basis, has sufficient contact to describe the subject's symptoms, and has
direct observation of the subject's behavior.

- Subject is able to comply with the protocol requirements.

Exclusion Criterion:

- Subjects who, in the opinion of the investigator, medical monitor, or sponsor should
not participate in the trial.
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