"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
| City: |
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Sun City |
| State: |
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Arizona |
| Zip Code: |
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85351 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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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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| Study Summary: |
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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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| Criteria: |
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Inclusion Criteria:
- Subjects must have a screening diagnosis of Probable Alzheimer's disease according to
National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's
Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26
- Subject must live at home.
- Must have a caregiver to participate in this study
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| NCT ID: |
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NCT01094340 |
| Primary Contact: |
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Study Director
Carolyn Liebsack, BSN
Banner Sun Health Research Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Sun City, Arizona 85351
United States
Marwan Sabbagh, MD
Phone: 623-832-6500
Email: marwan.sabbagh@bannerhealth.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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