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March 16, 2017

Alzheimer's Trial


Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by University of Colorado, Denver
University of Colorado, Denver
The Dana Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
First received: August 2, 2011
Last updated: January 24, 2017
Last verified: January 2017
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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:

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
Drug Information available for: Sargramostim
Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease
U.S. FDA Resources

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 ]
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 ]
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: December 2017
Estimated Primary Completion Date: November 2017 (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:
Granulocyte-Macrophage Colony-Stimulating Factor
Placebo Comparator: Control Group
Saline -- placebo comparator. Given as a subcutaneous injection.
Drug: Saline -- placebo comparator
subcutaneous injection
Other Name: Sterile solution of sodium chloride in water

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.

Ages Eligible for Study: 55 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:

age 55 to 85 years;
should have a mild-to-moderate Alzheimer's Disease diagnosis (Mini-Mental State Examination 10-26 inclusive);
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 Criteria:

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;
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

Contact: Joseph Daniels, MPH 303-724-2997 Joseph.Daniels@ucdenver.edu
Contact: Helen Gray, MBA 303-724-8965 Helen.Gray@ucdenver.edu

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
Sponsors and Collaborators
University of Colorado, Denver
The Dana Foundation
Principal Investigator: Huntington Potter, PhD University of Colorado, Denver
More Information

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: January 24, 2017

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 16, 2017

Posted by Rob Kiser on March 16, 2017 at 9:53 PM


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