At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 232 enrolled
Drug / intervention
Aripiprazole (BMS-337039) +1 moredrug
Likely dose
Aripiprazole (BMS-337039) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Sep 21, 2011·Updated Dec 2, 2013
In Brief
A Phase 3 clinical trial evaluating Aripiprazole (BMS-337039) and Placebo for Dementia, Alzheimer Type. Completed, enrolled 232 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia, Alzheimer Type
Countries--
CollaboratorsOtsuka America Pharmaceutical
Timeline
Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2000
Primary CompletionJul 2010
First PostedSep 2011
TodayJul 2026
First PostedSep 21, 2011
Enrollment StartAug 1, 2000
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 14.8 years ago
Interventions
Aripiprazole (BMS-337039)drug
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
Placebodrug
Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks