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

This study has been terminated.
(The study was discontinued prematurely on 25 February 2008 due to slow enrollment)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160147
First received: September 8, 2005
Last updated: June 12, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
 Drug: bifeprunox
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bifeprunox
One week titration with dose adjustments
Placebo Comparator: 2 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160147

  Hide Study Locations
Locations
United States, Arizona
Site 912
Phoenix, Arizona, United States
United States, California
Site 902
Carson, California, United States
Site 903
Long Beach, California, United States
Site 911
Pasadena, California, United States
Site 922
San Marino, California, United States
Site 910
Santa Ana, California, United States
United States, Connecticut
Site 929
Hamden, Connecticut, United States
Site 914
New Britain, Connecticut, United States
Site 931
Norwalk, Connecticut, United States
United States, Florida
Site 901
Miami, Florida, United States
Site 907
North Miami, Florida, United States
Site 933
Orange City, Florida, United States
United States, Georgia
Site 934
Atlanta, Georgia, United States
Site 917
Blue Ridge, Georgia, United States
Site 925
Newnan, Georgia, United States
United States, Louisiana
Site 904
New Orleans, Louisiana, United States
Site 905
Shreveport, Louisiana, United States
Site 906
Shreveport, Louisiana, United States
United States, Massachusetts
Site 919
Bedford, Massachusetts, United States
Site 923
Boston, Massachusetts, United States
United States, Mississippi
Site 942
Flowood, Mississippi, United States
United States, Missouri
Site 927
St. Louis, Missouri, United States
Site 930
St. Louis, Missouri, United States
Site 940
St. Louis, Missouri, United States
United States, New York
Site 941
Olean, New York, United States
Site 921
Staten Island, New York, United States
United States, Ohio
Site 909
Cincinnati, Ohio, United States
United States, Oklahoma
Site 908
Oklahoma City, Oklahoma, United States
Site 916
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Site 935
Philadelphia, Pennsylvania, United States
United States, Tennessee
Site 932
Humboldt, Tennessee, United States
United States, Texas
Site 936
Austin, Texas, United States
Site 928
Dallas, Texas, United States
United States, Virginia
Site 913
Williamsburg, Virginia, United States
United States, Wisconsin
Site 918
Waukesha, Wisconsin, United States
Czech Republic
Site 803
Litomerice, Czech Republic
Site 802
Lnare, Czech Republic
Site 804
Praha, Czech Republic
Site 805
Skvorec, Czech Republic
Site 801
Tabor, Czech Republic
Estonia
Site 807
Viljandimaa, Estonia
Site 806
Voru Maakond, Estonia
Israel
Site 812
Bat Yam, Israel
Site 808
Beer Yaakov, Israel
Site 811
Hadera, Israel
Site 816
Pardes Hana, Israel
Site 810
Rehovot, Israel
Site 809
Tirat HaCarmel, Israel
Poland
Site 814
Choroszcz, Poland
Site 813
Gdansk, Poland
Site 815
Torun, Poland
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Loretta Stallings, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160147     History of Changes
Other Study ID Numbers: S154.3.016, 2005-003475-20
Study First Received: September 8, 2005
Last Updated: June 12, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Mental Disorders
Psychotic Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 23, 2013