Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 2 for:    Leukine and Alzheimer's disease
Previous Study | Return to List | Next Study

Study of the Safety & Efficacy of Granulocyte-Macrophage Colony-Stimulating Factor (Leukine) in the Treatment of Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Colorado, Denver
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: June 24, 2014
Last verified: June 2014

August 2, 2011
June 24, 2014
March 2011
January 2015   (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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 Granulocyte-Macrophage Colony-Stimulating Factor (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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
  • 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 - 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.
 
Recruiting
40
March 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. age 55 to 85 years;
  2. should have a mild-to-moderate Alzheimer's Disease diagnosis (Mini-Mental State Examination 10-26 inclusive);
  3. if on anti-dementia treatment should be on stable treatment for at least 2 months (i.e. cholinesterase inhibitor and/or Memantine or Axona);
  4. stable on all other medications for at least 30 days prior to screen;
  5. should be fluent in English;
  6. should be physically able to participate by medical history, clinical exam and tests;
  7. 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, any women who feel they are likely to become pregnant during the study, and prisoners
Both
55 Years to 85 Years
No
Contact: Joseph Daniels 303-724-2997 Joseph.Daniels@ucdenver.edu
Contact: Kelly Rodrigo 813-974-4904 krodrig5@health.usf.edu
United States
 
NCT01409915
12-1273
Yes
University of Colorado, Denver
University of Colorado, Denver
The Dana Foundation
Not Provided
University of Colorado, Denver
June 2014

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