Back to resultsStudy of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Psychosis associated with dementia of the Alzheimer's type
Eligibility Criteria
Inclusion Criteria: Institutionalized patients with Alzheimer's
Sites / Locations
- Local Institution
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Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00036114
First Posted
May 7, 2002
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00036114
Brief Title
Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Psychosis associated with dementia of the Alzheimer's type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aripiprazole
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Institutionalized patients with Alzheimer's
Facility Information:
Facility Name
Local Institution
City
Tuscaloosa
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
Cerritos
State/Province
California
Country
United States
Facility Name
Local Institution
City
Granada Hills
State/Province
California
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
Torrance
State/Province
California
Country
United States
Facility Name
Local Institution
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Local Institution
City
Hamden
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Miami
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
North Miami Beach
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Local Institution
City
North Chicago
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Local Institution
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Local Institution
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Newton Center
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Wellesley Hills
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Lyons
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
Albany
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Lawrence
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Montrose
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Northport
State/Province
New York
Country
United States
Facility Name
Local Institution
City
White Plains
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Local Institution
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Austin
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Wichita Falls
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Bennington
State/Province
Vermont
Country
United States
Facility Name
Local Institution
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34918337
Citation
Muhlbauer V, Mohler R, Dichter MN, Zuidema SU, Kopke S, Luijendijk HJ. Antipsychotics for agitation and psychosis in people with Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2021 Dec 17;12(12):CD013304. doi: 10.1002/14651858.CD013304.pub2.
Results Reference
derived
Learn more about this trial
Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
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