Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-25 @ 11:06 PM
Study NCT ID:
NCT01438060
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2011-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: