Sargramostim for Mild-to-Moderate Alzheimer's Disease

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

Recruiting Phase 2 Interventional Study
Alzheimer Disease
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
60 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for

This trial is looking for people aged 60 to 85 with mild-to-moderate Alzheimer's disease. Participants will receive an FDA-approved medicine called sargramostim for six months and will need to attend regular visits with a caregiver.

Are You a Good Fit for This Trial?
Must be taking Cholinesterase inhibitorsMemantine
Rules you out Deep vein thrombosisActive cancerSeizuresAutoimmune disease

You may be able to join if

  • I am between 60 and 85 years old.
  • I have a caregiver who can come to visits with me.
  • I can provide consent to participate.
  • I have mild or moderate Alzheimer's disease.
  • I have positive biomarkers for brain amyloid pathology.
  • I have a MoCA score between 4 and 24.
  • I have had a dental exam in the last 6 months.
  • I have been stable on my medications for the last 30 days.

You may not be able to join if

  • I have a first-degree relative diagnosed with Alzheimer's before age 55.
  • I have a BMI of 35 or higher.
  • I cannot read or write at a level needed for the trial.
  • I am a prisoner.
  • I have another neurological or psychiatric condition that affects my cognition.
  • I have a history of mood or anxiety disorders that affect my participation.
  • I have had serious blood clots in the past.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 report…
Contacts

Neurology Research, CU Department of Neurology

303-724-4644

NeuroResearch@cuanschutz.edu

CONTACT