Start:
February 2016
End:
March 2017
Enrollment:
30
What Is This Study About?
This study will test the safety and effects on cognitive performance of the drug sargramostim (Leukine®) in people with mild cognitive impairment (MCI) due to Alzheimer's disease.
Do I Qualify To Participate in This Study?
Must have:
- Diagnosis of MCI due to Alzheimer's disease, with sporadic or familial inheritance pattern
- Evidence of concern about change in cognition, such as subjective memory complaint/decline for more than 6 months
- Objective impairment of memory function, documented by cognitive test score
- Evidence of elevated cortical amyloid by positron emission tomography (PET)
- Dedicated partner/caregiver who can assist participant with study procedures and taking study medication, who is with participant at least 12 hours a week
Must NOT have:
- Impairment(s) in activities of daily living
- Prior treatment with an investigational anti-amyloid therapy; investigational drug within prior 60 days, or within 5 times the elimination half-life of that drug, whichever is longest
- Unable to complete lumbar puncture or magnetic resonance imaging (MRI); exposure to ionizing radiation that would, together with the radiation in this study, exceed recommendations for annual or lifetime exposure
- Modified Hachinski Ischemic Score of more than 4
- Other neurological or psychiatric condition that can impair cognition
- Imaging evidence of potentially significant intracranial abnormalities not related to Alzheimer's, such as major stroke, infections, cancer, hydrocephalus, multiple sclerosis; abnormal cerebrospinal fluid not consistent with Alzheimer's; MRI evidence of more than four microhemorrhages
- Prone to spontaneous amyloid-related imaging abnormalities (ARIA-H) and/or susceptible to adverse effects of ARIA-H
- Untreated or unstable medical condition that could interfere with study or require immune-stimulating, immune-suppressive, or immune-modulating treatment(s) during study
- History of asplenia, hyposplenia, or splenectomy (whatever the surgical reasons)
- Current mood or anxiety disorder, psychotic disorder, and/or substance-related disorder; suicidal or shows suicidal ideation
- Laboratory abnormalities indicative of untreated medical or hematologic condition that could increase risk or interfere study assessments, including untreated hypo- or hyperthyroidism, vitamin B12 deficiency, hyperleukocytic syndrome (including chronic myelogenous leukemia, Hodgkin and non-Hodgkin lymphoma), monoclonal gammopathy, and thrombocythemia
- Known renal dysfunction or serum creatinine >150 µmol/L; known hepatic dysfunction (apart from Gilbert's syndrome) or serum alanine aminotransferase (ALT) ≥3 times the upper limit of normal
- Pregnant or breastfeeding
- Presence or history of drug hypersensitivity or known hypersensitivity to sargramostim, yeast-derived products, any other component of the product, or benzyl alcohol (present in bacteriostatic water or saline for infusion)
- Evidence of fluid retention (clinical or radiological), respiratory symptoms, cardiovascular symptoms, or electrocardiographic evidence of cardiac disease that warrant therapeutic intervention
- History of deep vein thrombosis (DVT), pulmonary embolism, or familial predisposition for DVT or pulmonary embolism
- Women and female partners of childbearing potential not using highly effective contraception
- History of latex allergy or yeast allergy
- Unable to cooperate because of language problem or poor mental development
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at
800-438-4380
or
email ADEAR.
Where Is This Study Located?
Collaborator Sponsor
-
National Institute on Aging (NIA)
Source:
ClinicalTrials.gov ID:
NCT02667496