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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: Sagramostim
Drug: Saline -- placebo comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Phase 2 Trial of the Safety & Efficacy of Granulocyte-Macrophage Colony-Stimulating Factor (Leukine) in the Treatment of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: Control Group
Saline - Subcutaneous injection
Drug: Saline -- placebo comparator
subcutaneous injection

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409915

Contacts
Contact: Joseph Daniels 303-724-2997 Joseph.Daniels@ucdenver.edu
Contact: Kelly Rodrigo 813-974-4904 krodrig5@health.usf.edu

Locations
United States, Colorado
University of Colorado Denver, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Joseph S Daniels, MPH, ACSM    303-724-2997    joseph.daniels@ucdenver.edu   
Principal Investigator: Huntington Potter, PhD         
Sub-Investigator: Jonathan Woodcock, MD         
United States, Florida
USF Byrd Alzheimer's Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Kelly Rodrigo, BA, CCRC    813-974-4904    krodrig5@health.usf.edu   
Principal Investigator: Ashok Raj, MD         
Sponsors and Collaborators
University of Colorado, Denver
The Dana Foundation
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01409915     History of Changes
Other Study ID Numbers: 12-1273
Study First Received: August 2, 2011
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Alzheimer's disease
neuropsychological assessment
Granulocyte-Macrophage Colony-Stimulating Factor
Leukine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014