Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD)
University of Colorado, Denver
Summary
A medicine that is FDA-approved for bone marrow stimulation (called sargramostim) will be tested for its safety and efficacy in individuals with mild-to-moderate Alzheimer's disease over a six month treatment period.
Description
This trial protocol is designed to evaluate primarily whether the long-term use of sargramostim (recombinant human GM-CSF), administered seven days per week for six consecutive months (24 weeks), will be tolerated by and safe for use in participants with mild-to-moderate AD, secondarily whether sargramostim can slow, halt, or reverse cognitive decline, and exploratory whether sargramostim can slow, halt, or reverse decline in activities of daily living, reverse or improve several biomarkers associated with AD, as evaluated by multimodal neuroimaging techniques and blood and cerebrospinal fluid…
Eligibility
- Age range
- 60–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males or females between age 60 and 85 years, inclusive, at time of consent. * Have a dedicated partner/caregiver informant who is in the company of the participant at least 12 hours a week, who can accompany them to scheduled visits, and who is able to provide accurate reporting upon the behavioral, cognitive and functional abilities of the participant. * Be physically able to participate with adequate visual acuity and auditory discrimination. * Be willing / able to provide written informed consent or assent. * Must reside within a proximity of the study site that will…
Interventions
- DrugSargramostim
Sargramostim is a granulocyte macrophage colony stimulating factor that will be administered at a dose of 178.57 mcg/m2 per day subcutaneously, 7 days/week, for 24 weeks
- DrugSaline - placebo comparator
Saline will be administered subcutaneously, 7 days/week, for 24 weeks
Location
- University of Colorado Anschutz Medical CampusAurora, Colorado