Trial · NCT04390646
GnRH Therapy on Cognition in Down Syndrome
NCT04390646, Phase 2, Phase 3, Recruiting, Nelly Pitteloud
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GnRH Therapy on Cognition in Down Syndrome. Trials, record NCT04390646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04390646
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GnRH Therapy on Cognition in Down Syndrome
- NCT number
- NCT04390646
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 56 participants, estimated
- Lead sponsor
- Nelly Pitteloud
- Conditions
- Down Syndrome, Cognitive Decline, Alzheimer Disease, Early Onset, Olfaction Disorders
- Interventions
- GnRH, gonadorelin acetate, 0.9% NaCl
- First posted
- 2020-05-15
- Last updated
- 2024-02-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cognition | Baseline to end of treatment (Week 24) | Montreal Cognitive Assessment (MoCA) total score ranges between 0 and 30 (cut-off set at 26 for the healthy population) Higher scores reflect better performance. |
| Secondary | Dimensional change card sorting task (DCCS) | baseline to end of treatment (Week 24) | change in score of DCCS to assess executive functions |
| Secondary | Paired Associated Learning (PAL, part of the CANTAB battery) | baseline to end of treatment (Week 24) | change in score of PAL to assess learning |
| Secondary | Token test | baseline to end of treatment (Week 24) | change in score of Token test to assess verbal comprehension |
| Secondary | Corsi block tapping task | baseline to end of treatment (Week 24) | change in score to assess visuospatial memory |
| Secondary | Litmus non-word-repetition test | baseline to end of treatment (Week 24) | change in score of Litmus test to assess phonological abilities |
| Secondary | Health-related quality of life SF-12 | baseline to end of treatment (Week 24) | The health-related quality of life (HRQoL) can be used to measure the effects of healthcare interventions and provide quality-improvement outcomes. The Short Form-12 (SF-12) Health Survey is widely used in measuring HRQoL. SF-12 is a reliable, valid measure in a variety of population groups; it is an equivalent substitute for the SF-36v2 for the summary scales. The response to each of the 12 items is weighted separately by the physical and mental component summary (PCS and MCS) regression coefficients and then calculated to give the SF-12 PCS and MCS scores. |
| Secondary | Adaptive behavior (Vineland II) - caregiver questionnaire | baseline to end of treatment (Week 24) | change in score of Vineland II (normed assessment tool that assesses adaptive behavior across the areas of communication, activities of daily living, and socialization). |
| Secondary | Glycemia | baseline to end of treatment (Week 24) | Glucose concentration (mmol/L) is a metabolic parameter. |
| Secondary | Insulinemia | baseline to end of treatment (Week 24) | Insulin concentration (nmol/L) is a metabolic parameter. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36048943 | RESULT |
Source PubMed
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.
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 |
|---|---|---|
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Token Commands Task | 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/NCT04390646
GET https://conductscience.org/api/trials/v1/NCT04390646/registered