Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01409915 |
Recruitment Status :
Completed
First Posted : August 4, 2011
Results First Posted : March 23, 2021
Last Update Posted : June 2, 2021
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Sponsor:
University of Colorado, Denver
Collaborator:
The Dana Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
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Tracking Information | ||||
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First Submitted Date ICMJE | August 2, 2011 | |||
First Posted Date ICMJE | August 4, 2011 | |||
Results First Submitted Date ICMJE | February 25, 2021 | |||
Results First Posted Date ICMJE | March 23, 2021 | |||
Last Update Posted Date | June 2, 2021 | |||
Study Start Date ICMJE | March 2011 | |||
Actual Primary Completion Date | December 9, 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Adverse Events (AEs) by Body System [ Time Frame: 20 weeks (From Consent to Follow-up 2) ] Count of AE's from Consent to Follow-up 2 within a safety analysis set consisting of all participants who were enrolled and randomized and who received at least one injection of sargramostim or placebo
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Original Primary Outcome Measures ICMJE |
Ability of AD subjects to tolerate Leukine treatment will be assessed [ Time Frame: 6 months ] Various tests of well being and toxicity will be monitored for 6 months after treatment
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Ability of Leukine treatment to improve cognition of AD subjects [ Time Frame: 6 months ] Neuropsychological measures will be assessed at various intervals up to 6 months following treatment (or placebo)
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease | |||
Official Title ICMJE | Pilot Phase 2 Trial of the Safety & Efficacy of Granulocyte-Macrophage Colony-Stimulating Factor (Leukine®) in the Treatment of Alzheimer's Disease | |||
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 reversed memory deficits in transgenic mouse models of Alzheimer's Disease (AD). To assess the efficacy of GM-CSF in humans, the investigators 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, the investigators 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer's Disease | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
44 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date ICMJE | December 9, 2019 | |||
Actual Primary Completion Date | December 9, 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 55 Years to 85 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01409915 | |||
Other Study ID Numbers ICMJE | 12-1273 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | University of Colorado, Denver | |||
Original Responsible Party | Gloria Mokry, University of South Florida | |||
Current Study Sponsor ICMJE | University of Colorado, Denver | |||
Original Study Sponsor ICMJE | University of South Florida | |||
Collaborators ICMJE | The Dana Foundation | |||
Investigators ICMJE |
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PRS Account | University of Colorado, Denver | |||
Verification Date | May 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |