Trial · NCT05482334
Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome
NCT05482334, Phase 2, Withdrawn, University of Colorado, Denver
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome. Trials, record NCT05482334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05482334
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome
- NCT number
- NCT05482334
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Down Syndrome
- Interventions
- Sargramostim for Injection, Saline Placebo
- First posted
- 2022-08-01
- Last updated
- 2025-04-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety as measured by number of Adverse Events (AEs) by body system | Informed consent to Follow-up Visit (20 weeks) | The safety of sargramostim will be assessed through number of adverse events (AEs) by body system from consent to follow-up within a safety analysis set consisting of all individuals who were enrolled and and randomized and who received at least one injection of sargramostim or placebo. |
| Secondary | Down syndrome Mental Status Exam (DSMSE) | Baseline to End of Treatment, Follow-up (20 weeks) | The DSMSE provides a broad assessment of cognitive function specially designed for use within the population of individuals with Down syndrome. Similar to the MMSE, the range for scores in the DMSE is from 0 to 30, with lower scores indicating greater impairment. |
| Other | Leiter 3 International Performance Scale (selected subtests) | Baseline to End of Treatment, Follow-up (20 weeks) | The Leiter 3 cognitive battery provides a broad non-verbal assessment of cognitive function, including executive function and spatial processing. We will employ the Sustained attention, and Forward and Backward Memory to assess inhibitory control, cognitive flexibility, working memory, and spatial processing respectively. |
| Other | CANTAB - Cambridge Neuropsychological Test Automated Battery) (selected subtests) | Baseline to End of Treatment, Follow-up (20 weeks) | The Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses motor response time and working memory quickly and reliably in individuals with Down syndrome. The CANTAB Paired Associate Learning subdomain will be used to measure episodic learning and memory. |
| Other | NEPSY II (selected subtest) | Baseline to End of Treatment, Follow-up (20 weeks) | The NEPSY II visuomotor subtest is a well validated neuropsychological assessment of visuomotor integration and motor control. |
| Other | KBIT II - Kaufman Brief Intelligence Test II | Baseline to End of Treatment, Follow-up (20 weeks) | The KBIT II is a brief measure of intelligence that yields scores in three area, verbal, nonverbal, and overall score (IQ composite) through questions of verbal knowledge, riddles and matrices. |
| Other | PPVT 5 - Peabody Picture Vocabulary Test, 5th edition | Baseline to End of Treatment, Follow-up (20 weeks) | The PPVT 5 is a receptive vocabulary task that is non-expressive language in nature which has participants point to pictures in response to specific questions on vocabulary |
| Other | SB 5 - Stanford Binet Intelligence Scales 5th edition (selected subtest) | Baseline to End of Treatment, Follow-up (20 weeks) | The SB 5 is a widely used and well validated measure of intelligence across the lifespan. The Nonverbal Working Memory task of the SB 5 will assess the working memory of the participants in a non-verbal manner. |
| Other | Patient-Reported Outcomes Measurement Information System (PROMIS) survey of quality of life | Baseline to End of Treatment, Follow-up (20 weeks) | The NIH PROMIS tool is a rigorously tested patient reported outcome (PRO) measurement tool that uses recent advances in information technology, psychometrics, and qualitative, cognitive, and health survey research to measure PROs such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. |
| Other | Vineland Adaptive Behavior Scales | Baseline to End of Treatment, Follow-up (20 weeks) | The Vineland scale is a well validated instrument that uses comprehensive caregiver report to develop metrics on 3 domains and 9 subdomains (Communication- Receptive, Expressive and Written; Daily Living Skills-Personal, Domestic, and Community; and Socialization-Interpersonal Relationships, Play and Leisure, and Coping Skills) to measure and assess adaptive behavior. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R61AG074859 | GM-CSF/sargramostim treatment to improve cognition in Down syndrome | POTTER, HUNTINGTON | UNIVERSITY OF COLORADO DENVER | NATIONAL INSTITUTE ON AGING | 2021 to 2022 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paired Associate Learning | Other outcome | ConductCognition |
| Vocabulary Test | Other outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05482334
GET https://conductscience.org/api/trials/v1/NCT05482334/registered