NCT01438060

Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 55 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia, Alzheimer Type

Interventions

Type	Name	Description
DRUG	Aripiprazole (BMS-337039)	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
DRUG	Placebo	Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks

Timeline

• Start date: 2000-08-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2011-09-21
• Last updated: 2013-12-02
• Results posted: 2012-03-05