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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Dana Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01409915
First received: August 2, 2011
Last updated: May 22, 2017
Last verified: May 2017
August 2, 2011
May 22, 2017
March 2011
November 2017   (Final data collection date for primary outcome measure)
Ability of Alzheimer's Disease subjects to tolerate Leukine treatment will be assessed [ Time Frame: Up to 5 months ]
Various tests of well being and toxicity will be monitored for 3 months after treatment
Ability of AD subjects to tolerate Leukine treatment will be assessed [ Time Frame: 6 months ]
Various tests of well being and toxicity will be monitored for 6 months after treatment
Complete list of historical versions of study NCT01409915 on ClinicalTrials.gov Archive Site
Ability of Leukine treatment to improve cognition of Alzheimer's Disease subjects [ Time Frame: Up to 5 months ]
Neuropsychological measures will be assessed at various intervals up to 3 months following treatment (or placebo)
Ability of Leukine treatment to improve cognition of AD subjects [ Time Frame: 6 months ]
Neuropsychological measures will be assessed at various intervals up to 6 months following treatment (or placebo)
Not Provided
Not Provided
 
Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
Pilot Phase 2 Trial of the Safety & Efficacy of Granulocyte-Macrophage Colony-Stimulating Factor (Leukine®) in the Treatment of Alzheimer's Disease
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.
Preliminary preclinical results demonstrated that GM-CSF (Granulocyte macrophage colony-stimulating factor, e.g. Leukine®/Sargramostim) rapidly reduced cerebral amyloid deposition and completely reversed memory deficits in transgenic mouse models of Alzheimer's Disease (AD). To assess the efficacy of GM-CSF in humans, the investigators performed a retrospective analysis of a cognition study of human patients undergoing hematopoietic cell transplantation for cancer and who garner cognitive impairments from the chemotherapy or irradiation. In the patients that received a colony-stimulating factor (CSF) to stimulate the bone marrow and recover immune system function, the investigators found that those who received GM-CSF (Leukine®/Sargramostim) plus G-CSF (Filigrastim) significantly improved in cognitive function as compared to those who received G-CSF alone. These findings combined with over two decades of accrued safety data using recombinant human GM-CSF, Leukine®/Sargramostim, in elderly leukopenic patients, suggested that Leukine® should be tested as a treatment to reverse cerebral amyloid pathology and cognitive impairment in AD.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Sagramostim
    5 subjects 250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. Data and Safety Monitoring Board will then review data and recommend whether to continue at the same current recommended dose for additional subjects or to reduce the dose by half if excessive leukocytosis occurs
    Other Names:
    • Leukine
    • Granulocyte-Macrophage Colony-Stimulating Factor
  • Drug: Saline -- placebo comparator
    subcutaneous injection
    Other Name: Sterile solution of sodium chloride in water
  • Experimental: Sagramostim (Leukine)
    5 subjects 250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. Data and Safety Monitoring Board will then review data and recommend whether to continue at the same current recommended dose for additional subjects or to reduce the dose by half if excessive leukocytosis occurs
    Intervention: Drug: Sagramostim
  • Placebo Comparator: Control Group
    Saline -- placebo comparator. Given as a subcutaneous injection.
    Intervention: Drug: Saline -- placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2017
November 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. age 55 to 85 years;
  2. should have a mild-to-moderate AD diagnosis (MMSE 10-26 inclusive);
  3. should have evidence of elevated cortical amyloid by PET using florbetapir F18 (Amyvid) [i.e. a positive scan], assessed qualitatively according to the Amyvid product label.
  4. if on anti-dementia treatment should be on stable treatment for at least 2 months (i.e. cholinesterase inhibitor and/or Memantine or Axona);
  5. stable on all other medications for at least 30 days prior to screen;
  6. should be fluent in English;
  7. should be physically able to participate by medical history, clinical exam and tests;
  8. should have a study partner to accompany them to scheduled visits.

Exclusion Criteria:

  1. clinically relevant arrhythmias;
  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. diagnostic and Statistical Manual of Mental Disorders-IV criteria for a current major psychiatric disorder;
  8. sensitivity to yeast or yeast products;
  9. impaired kidney function as measured by a Glomerular Filtration Rate less than 60 milliliters/min;
  10. preexisting fluid retention, pulmonary infiltrates, or congestive heart failure;
  11. history of moderate-to-severe lung disease;
  12. history of moderate-to-severe liver disease;
  13. pregnant women, or any women who feel they are likely to become pregnant during the study;
  14. prisoners.
Sexes Eligible for Study: All
55 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01409915
12-1273
Yes
Not Provided
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
The Dana Foundation
Principal Investigator: Huntington Potter, PhD University of Colorado, Denver
University of Colorado, Denver
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP