Status:
COMPLETED
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
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Agitation Associated With Alzheimer's Disease
Alzheimer's Type
Eligibility:
All Genders
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 sub...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT02192554
Start Date
June 1 2014
End Date
May 1 2017
Last Update
April 30 2018
Active Locations (84)
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Tuscaloosa, Alabama, United States, 35404
2
Costa Mesa, California, United States, 92626
3
Lakewood, California, United States, 90805
4
Orange, California, United States, 92868