Status:
COMPLETED
Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
The Dana Foundation
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
Brief 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.
Detailed Description
Preliminary preclinical results demonstrated that GM-CSF (Granulocyte macrophage colony-stimulating factor, e.g. Leukine®/Sargramostim) rapidly reduced cerebral amyloid deposition and completely rever...
Eligibility Criteria
Inclusion
- age 55 to 85 years;
- should have a mild-to-moderate AD diagnosis (MMSE 10-26 inclusive);
- 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.
- if on anti-dementia treatment should be on stable treatment for at least 2 months (i.e. cholinesterase inhibitor and/or Memantine or Axona);
- stable on all other medications for at least 30 days prior to screen;
- should be fluent in English;
- should be physically able to participate by medical history, clinical exam and tests;
- should have a study partner to accompany them to scheduled visits.
Exclusion
- clinically relevant arrhythmias;
- a resting pulse less than 50;
- active cancer other than non-melanoma skin cancers;
- use of another investigatory drug within 2 months of screening;
- significant stroke or head trauma by history or MRI;
- contraindication for having a MRI;
- diagnostic and Statistical Manual of Mental Disorders-IV criteria for a current major psychiatric disorder;
- sensitivity to yeast or yeast products;
- impaired kidney function as measured by a Glomerular Filtration Rate less than 60 milliliters/min;
- preexisting fluid retention, pulmonary infiltrates, or congestive heart failure;
- history of moderate-to-severe lung disease;
- history of moderate-to-severe liver disease;
- pregnant women, or any women who feel they are likely to become pregnant during the study;
- prisoners.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01409915
Start Date
March 1 2011
End Date
December 9 2019
Last Update
June 2 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, United States, 80045