Trial · NCT07598643
Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1
NCT07598643, Phase 2, Recruiting, University of Colorado, Denver
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1. Trials, record NCT07598643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07598643
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1
- NCT number
- NCT07598643
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 92 participants, estimated
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Down Syndrome
- Interventions
- Tofacitinib Oral Solution, Placebo
- First posted
- 2026-05-20
- Last updated
- 2026-09-03
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and percentage of subjects experiencing treatment-emergent adverse events. | From screening to 1 month after end of treatment | Number, percentage, type, and severity of treatment-emergent adverse events (TEAEs) will be annotated over the 6-month period in the treatment arm and placebo arm. |
| Primary | Change in Kaufman Brief Intelligence Test, 2nd Edition Revised (KBIT-2 Revised) - Verbal Intelligence | Baseline, 6 months | Verbal Intelligence score, made up of the Verbal Knowledge and Riddles subtest, is a standardized measure of verbal cognitive ability. Raw scores,will be employed. Increase in scores indicate improvement in verbal cognitive performance. |
| Primary | Change in Kaufman Brief Intelligence Test, 2nd Edition Revised (KBIT-2 Revised) - Nonverbal Intelligence | Baseline, 6 months | The KBIT-2 Revised Nonverbal Intelligence score is a standardized measure of nonverbal reasoning ability and is made up of the Matrices subtest. We will be using the raw score. Increase in scores indicate improvement in nonverbal cognitive performance. |
| Primary | Change in Leiter 3 - Attention Sustained subtest | Baseline, 6 months | The Leiter-3 Attention Sustained subtest is a measure of inhibitory control. The raw score, calculated as the correct number of targets minus errors made across four trials, will be used. Increase in scores indicate improvement. |
| Primary | Change in Vineland Adaptive Behavior Scales 3 (VABS-3) - Sum of Domain Raw Scores | Baseline, 6 months | The Vineland Adaptive Behavior Scales, Third Edition (VABS-3) assesses adaptive functioning across communication, daily living skills, socialization, and motor domains. Domain raw scores will be summed to produce a composite raw score. . Increase in scores indicate improvement in adaptive functioning. |
| Primary | Change in Clinical Global Impressions (CGI) Scale - Improvement in Health (CGI-I-H) | Baseline, 6 months | The CGI-I scale, which ranges from 1 to 7, with 1 being "very much improved" and 7 being "very much worse" to assess changes in global health during the 6-month intervention period. Noteworthy, we will also collect the CGI-S score (severity) at each time point (baseline, 3 months - midpoint visit, and 6 months - endpoint visit). The CGI-I will be collected at 3 months and 6 months. |
| Secondary | Change in Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5) | Baseline, 6 months | The Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5) assesses receptive vocabulary. Growth Scale Values (GSV) are used to determine an individual's absolute progress over time and is sensitive to small changes . Increase in scores indicate improvement in receptive vocabulary ability. A Naturalistic Language Sample will be utilized to measure spontaneous expressive language. We will analyze total utterances and mean length of utterance. Increase in scores indicate improvement in expressive language skills |
| Secondary | Change in Naturalistic Language Sample | Baseline, 6 months | This measure evaluates spontaneous expressive language narration. We will analyze total utterances and mean length of utterance. |
| Secondary | Change in Developmental Behavior Checklist 2 (DBC-2) or Achenbach Child (or Adult) Behavior Checklist | Baseline, 6 months | The DBC-2 reports a statistically significant change in Developmental Behavioral Checklist-2 (DBC-2) T-scores within or between treatment arms. A decrease in score indicates improvement. Or the Achenbach is a caregiver-report measure of maladaptive behavior. This is a standardized questionnaire with available score norms by chronological age resulting in T-scores. We will analyze change in the internalizing and externalizing T-scores. |
| Secondary | Change in Social Responsiveness Scale 2 (SRS-2), School Age and Adult | Baseline, 6 months | The Social Responsiveness Scale, Second Edition (SRS-2) generates T-scores with a mean of 50 and a standard deviation of 10. . Increase in scores indicates greater severity of autism-related symptoms (worse outcome). Both total and social communication T-scores will be analyzed. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests3
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 |
|---|---|---|
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Dimensional Change Card Sort | Secondary outcome | ConductCognition |
| Vocabulary Test | Secondary 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/NCT07598643
GET https://conductscience.org/api/trials/v1/NCT07598643/registered