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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02192554

Enrollment

450

Registered

2014-07-17

Start date

2014-06-30

Completion date

2017-05-31

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

OPC-34712, brexpiprazole, Dementia, Alzheimer's Disease, Cognitive Disorders, Memory, Agitation

Brief 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Adverse Events (AEs)	Baseline to Month 2/Early Termination
Mini-Mental State Examination (MMSE) score	Baseline to Month 2/Early Termination

Countries

Bulgaria, Canada, Croatia, France, Germany, Russia, Serbia, Slovenia, Spain, Ukraine, United Kingdom, United States

Outcome results