Dementia, Alzheimer Type Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo Controlled Flexible Dose Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.
Open label Extension Phase: The 130-week Extension Phase was conducted to provide
information regarding long-term safety and efficacy of aripiprazole in participants who were
diagnosed at the onset of the Acute Phase with psychotic symptoms associated with dementia
of the Alzheimer's type who responded to treatment in the 10-week Acute Phase of this study.
Treatment beyond 140 week: A country-specific amendment for France, allowed participants
treated with aripiprazole who, according to the investigator's opinion, showed improvement
at the Week 140 visit to continue treatment beyond 140 weeks. The termination was to be
determined by clinical benefit to he participant.
Study design:
Acute Phase: Randomized, double-blind, placebo-controlled, flexible-dose, parallel-group
study.
Extension Phase: Open label; flexible-dose.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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