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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

Page last updated: August 23, 2015

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