Evaluation of Safety and Efficacy of Sargramostim in Alzheimer's Disease

Primary Objective

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.

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Description

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. 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: 1. Treatment/placebo injections 5X a week during treatment phase 2. Cognitive testing 3. Twice weekly blood draws 4. MRI scans 5. PET Scans 6. Heath questionnaires 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: Study participation last up to 9-1/2 months. 1. Screening period will last up to 8 weeks 2. Treatment period will last 24 weeks 3. Follow-up visit occurs 45 days after end of treatment

Details
Age
Adult
Eligibility
Compensation: participants will receive study related care and medication at no cost.

Key Eligibility Criteria:
Age: between 60-85 years old
Meet criteria for diagnosis of mild-to-moderate Alzheimer’s disease
Have a study partner with who 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
Be willing to have MRI
Compensation
Up to $500 for completing all study procedures
Locations

Brain Imaging Center (BIC)
CU-RIC
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Huntington Potter

Huntington Potter

Resources
Study ID

Protocol Number: 19-2727

More information available at ClinicalTrials.gov: NCT04902703

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