Study of the Safety & Efficacy of GM-CSF (Leukine) in the Treatment of Alzheimer's Disease
Information source: University of South Florida
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Sagramostim (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of South Florida Overall contact:
Ashok Raj, MD, Phone: 813-396-0606, Email: braj@health.usf.edu
Summary
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.
Clinical Details
Official title: Pilot Phase 2 Trial of the Safety & Efficacy of GM-CSF (Leukine) in the Treatment of Alzheimer's Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Ability of AD subjects to tolerate Leukine treatment will be assessed
Secondary outcome: Ability of Leukine treatment to improve cognition of AD subjects
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Ashok Raj, MD, Phone: 813-396-0606, Email: braj@health.usf.edu
USF Byrd Alzheimer's Institute, Tampa, Florida 33613, United States; Recruiting
Ashok Raj, MD, Principal Investigator
Additional Information
Starting date: March 2011
Last updated: July 16, 2012
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