RecruitingAlzheimer Disease
Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease
Eligible age
60–85 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: University of Colorado, Denver
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Individuals with a first degree relative diagnosed with AD before 55 years of age.
- ✕ BMI ≥35.
- ✕ Is unable to read/write at an appropriate level to reliably participate in clinical trial psychometric assessments.
- ✕ Is a prisoner.
- ✕ Other neurological or psychiatric condition (other than AD) that can impact cognition, as well as atypical presentations of AD and AD related dementias, including logopenic primary progressive aphasia (PPA), or posterior cortical atrophy (PCA); or, CT/MRI evidence of potentially significant intracranial abnormalities not related to AD (e.g., evidence of major stroke or lacune in an area critical to cognition, infections, cancer, hydrocephalus, multiple sclerosis, etc.); or abnormal CSF not consistent with AD.
- ✕ Presence of current, serious mood or anxiety disorder, and/or a psychotic disorder, and/or a substance-related disorder according to Diagnostic and Statistical Manual of Psychiatric Disorders, Edition IV, text revision (DSM-IV-TR) or DSM-V that, in the opinion of the Principal Investigator, might impact cognitive assessment, affect participants ability to complete the study, or confound interpretation of the study drug effect; or is considered suicidal or shows suicidal ideation as assessed by the study physician
- ✕ History of deep vein thrombosis, pulmonary embolism, familial predisposition for deep vein thrombosis, or pulmonary embolism.
- ✕ Active cancer / malignant neoplasm within 5 years of screening other than non-melanoma skin cancers (e.g. Basal cell or squamous cell). Previous diagnosis of Leukemia, despite remission state or length of time, is considered exclusionary.
Where it's recruiting
Colorado
Aurora
Source: ClinicalTrials.gov · NCT04902703 · last updated 2026-04-30