Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease

Sponsored by University of South Florida

Phase Quota
Phase 2

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.

Study Start Date: March 2011

Estimated Completion Date: July 2016

Specialties: Internal Medicine: Neurology Nursing: Neurology Neurology: Dementia Physician Assistant: Neurology


  • Drug: Saline -- placebo comparator
  • Drug: Sagramostim

Inclusion criteria

  • Age 55 or older
  • Should have a mild to moderate AD diagnosis (MMSE 10-26 inclusive)
  • If on anti-dementia treatment should be on stable treatment for at least 2 months (ie cholinesterase inhibitor and/or Memantine or Axona)
  • Should be fluent in English,
  • Should be be physically able to participate by medical history, clinical exam and tests,
  • Should have a study partner to accompany them to scheduled visits

Exclusion criteria

  • Clinically relevant arrythmias,
  • A resting pulse less than 50,
  • Active cancer other than non melanoma skin cancers,
  • Use of another investigatory drug within 2 months of screening,
  • Significant stroke or head trauma by history or MRI
  • Contraindication for having a MRI
  • DSMIV criteria for a current major psychiatric disorder, and
  • Sensitivity to yeast or yeast products

Study Locations And Contact Information

  • University of Colorado Denver Anschutz Medical Campus, Aurora Colorado
    Contact: Joseph S Daniels MPH ACSM 303-724-2997

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