← Back to Search

Cytokine

Sargramostim for Down Syndrome

Phase 2
Recruiting
Led By Peter Pressman, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be stable on all other medications for at least 30 days prior to initial screening visit
Males or females with Down syndrome between 18-35 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up informed consent to follow-up visit (20 weeks)
Awards & highlights

Study Summary

This trial will test if a drug is safe and tolerated by young adults with Down Syndrome.

Who is the study for?
Adults with Down syndrome aged 18-35, who have a caregiver available for support, can participate in this trial. They must be healthy enough to join, not pregnant or planning pregnancy, and live close to the study site. Participants need recent thyroid checks and stable medication use.Check my eligibility
What is being tested?
The trial is testing Sargramostim (GM-CSF), given five days a week for four weeks, against a saline placebo to see if it's safe and tolerable for young adults with Down syndrome.See study design
What are the potential side effects?
Potential side effects of Sargramostim may include allergic reactions due to yeast-derived products or other components in the drug, fluid retention issues like swelling or weight gain, respiratory symptoms such as difficulty breathing, and blood pressure changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My medications have been the same for the last 30 days.
Select...
I am between 18-35 years old and have Down syndrome.
Select...
I have been diagnosed with Down syndrome.
Select...
I have a caregiver who can be with me for at least 12 hours a week and come to my appointments.
Select...
I can give my consent or have someone legally authorized to do so on my behalf.
Select...
I can see and hear well enough to participate in the trial.
Select...
I've been tested for hypothyroidism in the last 6 months and am stable on my medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~informed consent to follow-up visit (20 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and informed consent to follow-up visit (20 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety as measured by number of Adverse Events (AEs) by body system
Secondary outcome measures
Down Syndrome
Other outcome measures
CANTAB - Cambridge Neuropsychological Test Automated Battery) (selected subtests)
KBIT II - Kaufman Brief Intelligence Test II
Leiter 3 International Performance Scale (selected subtests)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SargramostimExperimental Treatment1 Intervention
Sargramostim 250 μg/m2/day subcutaneously (5 days per week)
Group II: Placebo Control - SalinePlacebo Group1 Intervention
Placebo equivalent volume subcutaneously (5 days per week)

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,658 Previous Clinical Trials
28,004,457 Total Patients Enrolled
9 Trials studying Down Syndrome
1,305 Patients Enrolled for Down Syndrome
University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,650 Total Patients Enrolled
8 Trials studying Down Syndrome
3,576 Patients Enrolled for Down Syndrome
Peter Pressman, MDPrincipal InvestigatorCU Alzheimer's and Cognition Center
1 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

Sargramostim (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT05482334 — Phase 2
Down Syndrome Research Study Groups: Sargramostim, Placebo Control - Saline
Down Syndrome Clinical Trial 2023: Sargramostim Highlights & Side Effects. Trial Name: NCT05482334 — Phase 2
Sargramostim (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05482334 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Sargramostim for Injection a safe option for patients to utilize?

"Reassessment of safety data has given Sargramostim for Injection a score of 2, as there is evidence to indicate its harmlessness but none yet suggesting it works."

Answered by AI

Are elderly patients eligible to participate in this particular clinical trial?

"This research is seeking out participants who have exceeded the age of consent yet remain younger than 35."

Answered by AI

Are there currently any vacancies for individuals to partake in this clinical trial?

"Clinicaltrials.gov confirms that this clinical trial, which was initially uploaded on January 1st 2023 and modified lastly on November 9th 2022, is no longer recruiting patients. Luckily, 1387 other studies are presently in the process of accepting volunteers."

Answered by AI

Are there any criteria for selection regarding who can partake in this clinical investigation?

"Eligibility criteria for this research stipulates that participants should have down syndrome and be 18 to 35 years of age. Currently, the project is aiming to enlist approximately 42 individuals."

Answered by AI
~28 spots leftby Sep 2026