Study of the Safety & Efficacy of Leukine� in the Treatment of Alzheimer's Disease
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Sagramostim (Drug); Saline -- placebo comparator (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Colorado, Denver Official(s) and/or principal investigator(s):
Huntington Potter, PhD, Principal Investigator, Affiliation: University of Colorado, Denver
Overall contact:
Joseph Daniels, Phone: 303-724-2997, Email: Joseph.Daniels@ucdenver.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 Granulocyte-Macrophage Colony-Stimulating Factor (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 Alzheimer's Disease subjects to tolerate Leukine treatment will be assessed
Secondary outcome: Ability of Leukine treatment to improve cognition of Alzheimer's Disease subjects
Detailed description:
Preliminary preclinical results demonstrated that GM-CSF (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, we
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, we 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.
Eligibility
Minimum age: 55 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Joseph Daniels, Phone: 303-724-2997, Email: Joseph.Daniels@ucdenver.edu
University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado 80045, United States; Recruiting
Joseph S Daniels, MPH, ACSM, Phone: 303-724-2997, Email: joseph.daniels@ucdenver.edu
Huntington Potter, PhD, Principal Investigator
Jonathan Woodcock, MD, Sub-Investigator
USF Byrd Alzheimer's Institute, Tampa, Florida 33613, United States; Recruiting
Kelly Rodrigo, BA, CCRC, Phone: 813-974-4904, Email: krodrig5@health.usf.edu
Ashok Raj, MD, Principal Investigator
Additional Information
Starting date: March 2011
Last updated: August 7, 2015
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