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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:
ClinicalTrials.gov Identifier:
NCT00160147
First Posted: September 12, 2005
Last Update Posted: February 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Solvay Pharmaceuticals
September 8, 2005
September 12, 2005
February 9, 2015
December 2005
January 2008   (Final data collection date for primary outcome measure)
Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: 10 weeks ]
Not Provided
Complete list of historical versions of study NCT00160147 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 10 weeks ]
Not Provided
Not Provided
Not Provided
 
Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
  • Drug: bifeprunox
    One week titration with dose adjustments
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: bifeprunox
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Estonia,   Israel,   Poland,   United States
Canada
 
NCT00160147
S154.3.016
2005-003475-20
Not Provided
Not Provided
Not Provided
Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP