Actively Recruiting

Phase 2
Age: 60Years - 85Years
All Genders
NCT04902703

Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease

Led by University of Colorado, Denver · Updated on 2026-04-30

42

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease

Who Can Participate

Age: 60Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Have a diagnosis of mild or moderate AD or a provisional research diagnosis consistent with probable mild or moderate AD.
  • MoCA score of 4-24 inclusive.
  • Have positive biomarker for brain amyloid pathology shown by positive plasma assay for Ab2(42)/ Ab2(40) ratio AND either positive CSF assay for AD assessment or positive amyloid PET, per PI read.
  • If receiving anti-dementia treatment, be on stable treatment for at least 60 days 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.
Not Eligible

You will not qualify if you...

  • Individuals with a first degree relative diagnosed with AD before 55 years of age.
  • BMI e535.
  • Unable to read/write at an appropriate level to reliably participate in clinical trial psychometric assessments.
  • Is a prisoner.
  • Other neurological or psychiatric conditions (other than AD) that can impact cognition or atypical AD presentations.
  • CT/MRI evidence of significant intracranial abnormalities not related to AD.
  • Presence of current serious mood, anxiety, psychotic, or substance-related disorder that might impact cognitive assessment or study participation.
  • History of deep vein thrombosis, pulmonary embolism, or familial predisposition.
  • Active cancer within 5 years other than certain skin cancers.
  • History of latex or yeast allergy.
  • History of drug hypersensitivity or known hypersensitivity to sargramostim or components.
  • History of asplenia, hyposplenia, or splenectomy.
  • History or treatment for autoimmune disease.
  • Untreated or unstable medical conditions that could interfere with study assessments or require immune-modulating treatments.
  • History of seizures (except infant febrile seizures).
  • Pregnant or breastfeeding females or females of childbearing potential not using effective contraception; males refusing condom use if partner can get pregnant.
  • MRI evidence of more than 4 micro-hemorrhages.
  • Laboratory results indicating untreated medical or hematologic condition increasing risk.
  • Clinically significant pre-existing fluid retention, moderate-to-severe lung disease, cardiac disease requiring treatment, pulse less than 50, prolonged QTc interval, or high blood pressure.
  • Known renal dysfunction or low glomerular filtration rate.
  • Known hepatic dysfunction or high serum ALT.
  • Positive serology for hepatitis B, hepatitis C, HIV, or spirochetal infection.
  • Contraindications to MRI or PET scans.
  • Sensitivity to fluorodeoxyglucose F 18.
  • Past or planned ionizing radiation exposure exceeding recommendations.
  • Poor venous access.
  • History of chronic or recurrent bacterial infections.
  • Taking prohibited medications or therapies.
  • Recipient of investigational drug within 60 days or 5 times drug half-life.
  • Prior treatment with investigational anti-amyloid or anti-tau therapy unless documented placebo.
  • Participation in investigational sargramostim trial within 6 months.
  • Likely non-compliance with protocol or inability to cooperate due to language or developmental disability.
  • Employees or relatives of study sponsors or investigators directly involved in the study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

N

Neurology Research, CU Department of Neurology

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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