Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD).
The purpose of this research study is to learn more about the safety and effectiveness of a drug called sargramostim for improving cognitive function and memory in people with Alzheimer’s disease.
Sargramostim is an investigational drug, meaning it has not been approved by the FDA to treat Alzheimer’s.
Sargramostim has been approved by the FDA for the past thirty years to treat patients who have had chemotherapy to boost the body’s innate immune system. This research study hopes to find out more about how sargramostim works within the body over a longer time period than previously studied.
Main Procedures Involved: These visits may include some of the following procedures: • Cognitive testing • Twice weekly blood draws • Heart Tracing (ECG) • Health Questionnaires • Study Partner Questionnaires • Lumbar Puncture (spinal tap) or an amyloid PET scan • MRI • PET scans (FDG PET and/or amyloid PET (as an entry criteria) • Treatment/placebo injection 5x a week during treatment phase If determined to be eligible during screening, you will be assigned to one of two arms of the study: 1) receives study medication; 2) receives placebo (a pill or a liquid that looks like medicine but is not real). Health insurance is not needed for this study.
Duration of Participation: Potential study participants will need to initially come to CU Anschutz Medical Campus in Aurora several times for screening visits. Once enrolled, participants will be able to have weekly home nursing visits to provide supplies and draw blood. Participants will only need to come to the CU Anschutz campus at the beginning, the middle, and the end of the study, as well as a post-study visit 45 days later. After initial screenings at the CU Anschutz campus in Aurora, CO, participants will be able to have weekly home nursing visits to provide supplies and draw blood. Occasional visits to campus during the study will be required for procedures that cannot be done at home. Including screening and follow-up, study participation last up to 9-1/2 months with up to 55 visits. • Screening period will last up to 8 weeks • Treatment period will last 24 weeks • Follow-up visit occurs 45 days after end of treatment Compensation: participants will receive study related care and medication at no cost. Key Eligibility Criteria: - Age: between 60-85 years old - Diagnosis: mild-to-moderate Alzheimer’s disease (AD) - Have a study partner with whom you at least 12 hours of contact a week and is willing to attend scheduled visits, can report changes in your thinking and memory, and is willing to be trained to give daily injections of study drug - Willing to have testing of sample collected from a lumbar puncture/spinal tap or an amyloid PET scan to confirm diagnosis of Alzheimer’s disease - Must not have a first degree relative diagnosed with AD before 55 years of age
Peter Pressman, MD
Protocol Number: 19-2727
More information available at ClinicalTrials.gov: NCT04902703
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