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:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160147
First received: September 8, 2005
Last updated: June 12, 2009
Last verified: June 2009
| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | June 12, 2009 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00160147 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Czech Republic, Estonia, Israel, Poland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00160147 | ||||
| Other Study ID Numbers ICMJE | S154.3.016, 2005-003475-20 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Loretta Stallings, Solvay Pharmaceuticals | ||||
| Study Sponsor ICMJE | Solvay Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Solvay Pharmaceuticals | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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