Study of the Safety and Effectiveness of Sargramostim for Alzheimer’s Disease
The purpose of this study is to learn if a drug called sargramostim is safe and if it can help improve thinking and memory in people with Alzheimer’s disease.
Why this Research Matters
Alzheimer’s disease is a common health condition in older adults and affects about 12% of people over age 65. Current drugs may slow down memory loss a little, but they cannot stop or undo the harm caused by the disease. Sargramostim is not approved by the Food and Drug Administration (FDA) to treat Alzheimer’s disease. This study wants to learn more about how sargramostim works in the body over a longer time and whether it can safely and effectively improve thinking and memory.
What to Expect
If you agree to join the study, your first visit will help decide if you qualify. You will be asked questions about your health and daily life, and you will get a blood test. Your Alzheimer's diagnosis will be confirmed with either a spinal tap or an amyloid PET scan. A PET scan is a type of imaging test that helps doctors look for disease inside the body. This screening part of the study will last about 12 weeks. If you qualify for the study, you will be randomly placed into either the treatment group or the placebo group, like flipping a coin. If you are in the treatment group, you will receive the study drug, sargramostim. If you are in the placebo group, you will get a medication that looks like the study drug but does not have any medical effect. During the treatment part of the study, you will get a daily shot of either the study drug or the placebo. You will take tests that measure your thinking and memory, fill out questionnaires, and have your blood drawn twice a week. You will also have MRI and PET scans so the study doctors can see how your brain is working. You do not have to pay to be in the study.
Study Duration
The treatment part will last for 24 weeks. You will have some in-person visits during the study. After you finish treatment, you will have a follow-up visit 45 days later. In total, you will be in the study for about ten and half months.
Who can Participate
You may be able to join the study if you are between 60 and 85 years old and have mild to moderate Alzheimer's disease. You must also have a study partner who can come to the scheduled visits, report any changes in your thinking and memory, and learn how to give daily shots of the study drug.
Study ID
Protocol Number: 19-2727
More information available at ClinicalTrials.gov: NCT04902703
Compensation Information
Meet the Team
Principal Investigator