Trial record 1 of 1 for:
Thalidomide AND "Marwan Sabbagh"
Thalidomide for Patients With Mild to Moderate Alzheimer's Disease
This study is currently recruiting participants.
Verified August 2012 by Banner Health
Sponsor:
Banner Health
Information provided by (Responsible Party):
Brian Browne, Banner Health
ClinicalTrials.gov Identifier:
NCT01094340
First received: March 25, 2010
Last updated: August 6, 2012
Last verified: August 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 25, 2010 | ||||
| Last Updated Date | August 6, 2012 | ||||
| Start Date ICMJE | March 2010 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Improve cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01094340 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| 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 | Thalidomide for Patients With Mild to Moderate Alzheimer's Disease | ||||
| Official Title ICMJE | "Twenty-Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fixed Dose Regimens of Thalidomide and Placebo on CSF and Plasma Biomarkers in Patients With Mild to Moderate Alzheimer's Disease | ||||
| Brief Summary | This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers. |
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| Detailed Description | A lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect CSF for the quantification of biomarkers. As an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the CSF. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Alzheimer's Disease | ||||
| Intervention ICMJE | Drug: Thalidomide
fixed dose over 8 clinic visits
Other Name: Celegene |
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| Study Arm (s) | Thalidoide
CSF
Intervention: Drug: Thalidomide |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | January 2013 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01094340 | ||||
| Other Study ID Numbers ICMJE | 1R01AG034155-01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Brian Browne, Banner Health | ||||
| Study Sponsor ICMJE | Banner Health | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Banner Health | ||||
| Verification Date | August 2012 | ||||
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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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