Conditions: Dementia, Alzheimer Type
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 232
Healthy volunteers: no

Brief summary:
The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.

Detailed description:
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.

Arms:
arm 1: Double blind Acute Phase (Week 1 to Week 10), Open label Extension Phase (Week 11 to Week 140) arm 2: Double blind Acute Phase (Week 1 to Week 10)

Interventions: intervention 1: Aripiprazole (BMS-337039) intervention 2: Placebo
Intervention descriptions: intervention 1: Acute Phase: Oral, Tablets (1 and 5 mg), Week 1-2: 2 mg, Week 3-4: 2 - 5 mg, Week 5-6: 2 - 10 mg, Weeks 7-10: 2 - 15 mg, Once daily, 10 weeks

Extension Phase: Oral, Tablets (1 and 5 mg), Week 11: 2 mg, Weeks 12-13: 2 - 5 mg, Weeks 14-15: 2 - 10 mg, Weeks 16-140: 2 - 15 mg, Once daily, 130 weeks intervention 2: Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks

Protocol document: