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 Details — Status: Completed

Administrative data

• NCT number: NCT02192554
• Other study ID #: 331-13-211
• Status: Completed
• Start date: June 2014
• Est. completion date: May 2017

Study information

• Verified date: April 2018
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Agitation Associated With Alzheimer's Disease
• Alzheimer Disease
• Alzheimer's Type
• Dementia
• Mental Disorder
• Mental Disorders
• Nervous System Diseases
• Psychomotor Agitation
• Psychotic Disorders

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	H. Lundbeck A/S

Countries where clinical trial is conducted

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

Outcome

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