NCT04902703

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial protocol is designed to evaluate primarily whether the long-term use of sargramostim (recombinant human GM-CSF), administered five days per week for six consecutive months (24 weeks), will be tolerated by and safe for use in participants with mild-to-moderate AD, secondarily whether sargramostim can slow, halt, or reverse cognitive decline, and exploratory whether sargramostim can slow, halt, or reverse decline in activities of daily living, reverse or improve several biomarkers associated with AD, as evaluated by multimodal neuroimaging techniques and blood and cerebrospinal fluid analyses. This trial extends the safety results from recently completed Phase 2 double-blind, placebo-controlled clinical trial in mild-to-moderate AD participants (NCT01409915, COMIRB#12-1273), using sargramostim that was administered five days per week for three consecutive weeks and in which there were no incidence of drug-related serious adverse events (SAEs).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Sargramostim	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
DRUG	Saline - placebo comparator	Saline will be administered subcutaneously, 7 days/week, for 24 weeks

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2021-05-26
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study