Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease
This study tests whether sargramostim, a medicine already approved by the FDA for stimulating bone marrow, can help slow memory loss and thinking problems in people with mild-to-moderate Alzheimer's disease. Participants will receive the medication for six months while researchers monitor its safety and effectiveness.
Key Objective:The trial is testing whether sargramostim can slow cognitive decline and improve brain function in people with mild-to-moderate Alzheimer's disease.
Who to Consider:People with mild-to-moderate Alzheimer's disease who are willing to commit to a six-month treatment period and regular study visits should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 not preclude their regularly-scheduled participation in the trial, as well as a catchment area for local lab blood draws (i.e. central contracted laboratory). * Meet criteria for probable AD dementia according to the National Institute of Aging - Alzheimer's Association (NIA-AA) 2018 core research criteria, and have the following at screening: * A diagnosis of mild AD or moderate AD, or * A provis