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Find more clinical trials

Sargramostim to Treat Mild Cognitive Impairment

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?

Minimum Age: 40 Years

Maximum Age: 80 Years

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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

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?

Who Sponsors This Study?

Lead: Sanofi

Collaborator Sponsor

  • National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT02667496

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health