Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Ty… (NCT02192554) | Clinical Trial Compass
CompletedNot Applicable
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
United States450 participantsStarted 2014-06
Plain-language summary
To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.
Who can participate
SexALL
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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.
What they're measuring
1
Adverse Events (AEs)
Timeframe: Baseline to Month 2/Early Termination
2
Mini-Mental State Examination (MMSE) score
Timeframe: Baseline to Month 2/Early Termination
Trial details
NCT IDNCT02192554
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.