Trial · NCT06465823
Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome
NCT06465823, Phase 2, Unknown, Stefano Vicari
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome. Trials, record NCT06465823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06465823
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome
- NCT number
- NCT06465823
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 64 participants, estimated
- Lead sponsor
- Stefano Vicari
- Conditions
- Down Syndrome
- Interventions
- Bumetanide, Placebo
- First posted
- 2024-06-20
- Last updated
- 2024-06-20
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual-Object long-term memory measures | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Visual-Object Learning test (PROMEA, Vicari, 2007) - Efficacy criterion. Test assesses long-term visual memory skills.The total raw score of the visual episodic memory trial, the raw learning scores for each immediate recall trial (R\_Score T1, T2, T3) and the raw score of the deferred recall trial (R\_ Score Deferred) will be evaluated. |
| Secondary | Verbal long-term memory measure | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Verbal Learning test (PROMEA, Vicari, 2007) - Efficacy criterion. Test assesses long-term verbal memory skills. The raw learning scores for each immediate recall trial (R\_ScoreT1, T2, T3) and the raw score of the deferred recall trial (R\_ Score Deferred) will be taken into account. |
| Secondary | Visual-Spatial long-term memory measure | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Visual-Spatial learning test (PROMEA, Vicari, 2007) - Efficacy criterion. Test assesses long-term spatial memory skills.The raw learning scores for each immediate recall trial (R\_ScoreT1, T2, T3) and the raw score of the deferred recall trial (R\_ Score Deferred) will be taken into account. |
| Secondary | Long-term memory measures : recollection and familiarity | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Processing Dissociation Procedure - PDP (Costanzo et al., 2013 - Efficacy criterion. Test assesses recollection and familiarity processes to memory performance..In the Processing Dissociation Procedures (PDP) test, of hits alarms responses (H) and false alarms responses (F) will be considered for both the "Inclusion" and "Exclusion" conditions. |
| Secondary | Long-term memory measure: associative memory | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Associative Memory (Costanzo et al., 2013) - Efficacy criterion. Test assesses recollection and familiarity processes to memory performance.The total raw scores for the "single item" and "associative item" condition and the learning raw scores for each trial of each condition (T1, T2, T3) will be evaluated. |
| Secondary | Long-term measure - child's everyday memory | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | The Observer Memory Questionnaire-Parent Form (OMQ-PF, Gonzalez et al., 2008) - Likert scale questionnaire, test assesses parental beliefs about their child's everyday memory.For the assessment of everyday memory skills, the raw total score will be considered. |
| Secondary | Adaptive level | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | ABAS II (Adaptive Behavior Assessment System Second Edition, Italian adaptation of Ferri R., Orsini A. e Rea M., Eds., 2014) - Efficacy criterion. Scale to obtain the parent's observations about the youth's behaviour and gives a complete overview of child and adolescent adaptive behaviours. |
| Secondary | Executive measure | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Behavior Rating Inventory Executive Function Second Edition (BRIEF 2, Gioia et al., 2000) Inventory evaluates everyday behaviors associated with EF in home and educational environments.The standardized scores (T) of Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task-Monitor,and Organization of Materials scales will be evaluated. Behavioral Regulation Index (BRI), Emotional Regulation Index (ERI), Cognitive Regulation Index (CRI) and Global Executive Composite Score (GEC) also will be assessed. |
| Secondary | Psychopathological measure - semi-structured diagnostic interview | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | K-Sads-Present and Lifetime Version (K-SADS-PL) (Kaufman et al., 2004) - Efficacy criterion. Interview assesses psychopathology according to the DSM-5 criteria.The total raw score related to current symptoms reported by the participant's parents in the interview and the symptom/disease decoding scores related to each diagnostic category will be evaluated. |
| Secondary | Psychopathological measure - behavioral and psychopathological aspects | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Conners' Parent Rating Scale -. Revised, Long Form (CPRS-R:L - Conners, 1997; Nobile, Alberti, \& Zuddas, 2007) - Efficacy criterion. Questionnaire used parent's observations about the youth's behaviour and gives a complete overview of child and adolescent psychopathological disorders.The T scores of each scale of the questionnaire will also be evaluated. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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.
Tests1
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 |
|---|---|
| Verbal Learning | Secondary outcome |
Source 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/NCT06465823
GET https://conductscience.org/api/trials/v1/NCT06465823/registered