Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD)
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.
• 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 provisional research diagnosis consistent with probable mild AD or moderate AD, and
⁃ MoCA score of 4-24 inclusive.
• Have positive biomarker for brain amyloid pathology as shown by:
‣ Positive plasma assay for Aβ(42)/ Aβ(40) ratio AND
⁃ Either postivie CSF assay for AD assessment or positive amyloid PET, per PI read.
• If receiving anti-dementia treatment (i.e. AChEI), be on stable treatment for at least 60 days (i.e., cholinesterase inhibitor and/or Memantine) before initial screening visit.
• Be stable on all other medications for at least 30 days prior to initial screening visit.
• Have had a dental exam within 6 months of date of screening.