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Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome

Down Syndrome Clinical Trial

Official title:
Phase II Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome

Clinical Trial Summary

This trial protocol is designed to evaluate primarily whether the use of sargramostim (recombinant human GM-CSF), administered five days per week for four consecutive weeks (20 treatment days), will be well tolerated by and safe for use in young adult participants with Down syndrome.

Clinical Trial Description

This trial protocol is designed to evaluate primarily whether the use of sargramostim (recombinant human GM-CSF), administered five days per week (250 μg/m2/day subcutaneously) for four consecutive weeks (20 treatment days), will be well tolerated by and safe for use in young adult participants (age 18-35) with Down Syndrome; Secondarily whether sargramostim will have an impact on cognition, and exploratory whether sargramostim has an impact upon activities of daily and quality of life, and impact upon several biomarkers associated with DS, as evaluated by multimodal neuroimaging techniques and blood analyses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05482334
Study type Interventional
Source University of Colorado, Denver
Contact Neurology Research Partners, CU Department of Neurology
Phone 303-724-4644
Email neurologyresearchpartners@cuanschutz.edu
Status Recruiting
Phase Phase 2
Start date October 23, 2023
Completion date September 2026
View Details
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