RecruitingPhase 2NCT04902703

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

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


Sponsor

University of Colorado, Denver

Enrollment

42 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether sargramostim (GM-CSF), a drug that stimulates the immune system and is already approved for other uses, can slow or improve symptoms of Alzheimer's disease in older adults with mild to moderate dementia. **You may be eligible if...** - You are between 60 and 85 years old - You have been diagnosed with mild or moderate Alzheimer's disease - You have a brain scan or blood test showing signs of amyloid protein buildup consistent with Alzheimer's - You have a dedicated caregiver who spends at least 12 hours per week with you and can attend visits - You scored between 4 and 24 on a standard memory test (MoCA) **You may NOT be eligible if...** - Your dementia is severe - You do not have a caregiver who can accompany you - You are unable to provide consent or assent - You live too far from the study site - You have serious health conditions that would prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSargramostim

Sargramostim is a granulocyte macrophage colony stimulating factor that will be administered at a dose of 178.57 mcg/m2 per day subcutaneously, 7 days/week, for 24 weeks

DRUGSaline - placebo comparator

Saline will be administered subcutaneously, 7 days/week, for 24 weeks


Locations(1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

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NCT04902703


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