Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
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.
Key facts
- Study ID
- NCT01409915
- Run by
- University of Colorado, Denver
- People needed
- 44
- Starts
- 2011-03-01
- Expected to finish
- 2019-12-09
- Last updated by the study team
- 2021-06-02
Who can join
Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Colorado Denver, Anschutz Medical Campus — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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