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

September 8, 2005
June 12, 2009
December 2005
January 2008   (final data collection date for primary outcome measure)
Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00160147 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
65 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Estonia,   Israel,   Poland
 
NCT00160147
S154.3.016, 2005-003475-20
Not Provided
Loretta Stallings, 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