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Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

Primary Purpose

Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bifeprunox
Placebo
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of dementia of the Alzheimer's type Exclusion Criteria: History of seizure disorder Clinically significant electrocardiogram (ECG) Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma

Sites / Locations

  • Site 912
  • Site 902
  • Site 903
  • Site 911
  • Site 922
  • Site 910
  • Site 929
  • Site 914
  • Site 931
  • Site 901
  • Site 907
  • Site 933
  • Site 934
  • Site 917
  • Site 925
  • Site 904
  • Site 905
  • Site 906
  • Site 919
  • Site 923
  • Site 942
  • Site 927
  • Site 930
  • Site 940
  • Site 941
  • Site 921
  • Site 909
  • Site 908
  • Site 916
  • Site 935
  • Site 932
  • Site 936
  • Site 928
  • Site 913
  • Site 918
  • Site 803
  • Site 802
  • Site 804
  • Site 805
  • Site 801
  • Site 807
  • Site 806
  • Site 812
  • Site 808
  • Site 811
  • Site 816
  • Site 810
  • Site 809
  • Site 814
  • Site 813
  • Site 815

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Brief Psychiatric Rating Scale (BPRS) Total Score

Secondary Outcome Measures

Adverse events

Full Information

First Posted
September 8, 2005
Last Updated
January 29, 2015
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00160147
Brief Title
Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
Official Title
A Randomized, Double-Blind, Placebo-controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued prematurely on 25 February 2008 due to slow enrollment
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances 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
Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
bifeprunox
Intervention Description
One week titration with dose adjustments
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS) Total Score
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of dementia of the Alzheimer's type Exclusion Criteria: History of seizure disorder Clinically significant electrocardiogram (ECG) Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 912
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Site 902
City
Carson
State/Province
California
Country
United States
Facility Name
Site 903
City
Long Beach
State/Province
California
Country
United States
Facility Name
Site 911
City
Pasadena
State/Province
California
Country
United States
Facility Name
Site 922
City
San Marino
State/Province
California
Country
United States
Facility Name
Site 910
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 929
City
Hamden
State/Province
Connecticut
Country
United States
Facility Name
Site 914
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Site 931
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
Site 901
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 907
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Site 933
City
Orange City
State/Province
Florida
Country
United States
Facility Name
Site 934
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 917
City
Blue Ridge
State/Province
Georgia
Country
United States
Facility Name
Site 925
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
Site 904
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Site 905
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Site 906
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Site 919
City
Bedford
State/Province
Massachusetts
Country
United States
Facility Name
Site 923
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Site 942
City
Flowood
State/Province
Mississippi
Country
United States
Facility Name
Site 927
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 930
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 940
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 941
City
Olean
State/Province
New York
Country
United States
Facility Name
Site 921
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Site 909
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 908
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 916
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 935
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 932
City
Humboldt
State/Province
Tennessee
Country
United States
Facility Name
Site 936
City
Austin
State/Province
Texas
Country
United States
Facility Name
Site 928
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Site 913
City
Williamsburg
State/Province
Virginia
Country
United States
Facility Name
Site 918
City
Waukesha
State/Province
Wisconsin
Country
United States
Facility Name
Site 803
City
Litomerice
Country
Czech Republic
Facility Name
Site 802
City
Lnare
Country
Czech Republic
Facility Name
Site 804
City
Praha
Country
Czech Republic
Facility Name
Site 805
City
Skvorec
Country
Czech Republic
Facility Name
Site 801
City
Tabor
Country
Czech Republic
Facility Name
Site 807
City
Viljandimaa
Country
Estonia
Facility Name
Site 806
City
Voru Maakond
Country
Estonia
Facility Name
Site 812
City
Bat Yam
Country
Israel
Facility Name
Site 808
City
Beer Yaakov
Country
Israel
Facility Name
Site 811
City
Hadera
Country
Israel
Facility Name
Site 816
City
Pardes Hana
Country
Israel
Facility Name
Site 810
City
Rehovot
Country
Israel
Facility Name
Site 809
City
Tirat HaCarmel
Country
Israel
Facility Name
Site 814
City
Choroszcz
Country
Poland
Facility Name
Site 813
City
Gdansk
Country
Poland
Facility Name
Site 815
City
Torun
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

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