View Clinical Trial (Medical Research Study)
Pilot Phase 2 Trial of the Safety & Efficacy of GM-CSF (Leukine) in the Treatment of Alzheimer's Disease
| City: |
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Tampa |
| State: |
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Florida |
| Zip Code: |
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33613 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested
for its ability to be tolerated by Alzheimer's disease patients and potentially to improve
their memory.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. age 55 or older
2. should have a mild to moderate AD diagnosis (MMSE 10-26 inclusive)
3. if on anti-dementia treatment should be on stable treatment for at least 2 months (ie
cholinesterase inhibitor and/or Memantine or Axona)
4. should be fluent in English,
5. should be be physically able to participate by medical history, clinical exam and
tests,
6. should have a study partner to accompany them to scheduled visits.
Exclusion Criteria:
1. clinically relevant arrythmias,
2. a resting pulse less than 50,
3. active cancer other than non melanoma skin cancers,
4. use of another investigatory drug within 2 months of screening,
5. significant stroke or head trauma by history or MRI
6. Contraindication for having a MRI
7. DSMIV criteria for a current major psychiatric disorder, and
8. sensitivity to yeast or yeast products.
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| NCT ID: |
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NCT01409915 |
| Primary Contact: |
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Ashok Raj, MD
Phone: 813-396-0606
Email: braj@health.usf.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tampa, Florida 33613
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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