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NCT01084135 · ClinicalTrials.gov registry record · Phase 1
Rivastigmine Study in Adolescents With Down Syndrome
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01084135: Completed Phase 1 study, sponsored by Duke University.
NCT01084135 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01084135, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if short term use of rivastigmine can improve functional abilities (for example, language, memory, and executive function) in adolescents with Down syndrome.
Primary Outcome
The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. In this study, the change between each subject's ABC at Baseline and the Final Visit was comput
Interventions
- DRUG Rivastigmine
- OTHER Liquid Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01084135 record still lists
NCT01084135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Rivastigmine is the first listed.
NCT01084135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01084135 about?
NCT01084135 is a clinical study titled "Rivastigmine Study in Adolescents With Down Syndrome". The purpose of this study is to determine if short term use of rivastigmine can improve functional abilities (for example, language, memory, and executive function) in adolescents with Down syndrome.
What is the current status of trial NCT01084135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2009-11. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01084135?
The interventions under investigation include: Rivastigmine (DRUG), Liquid Placebo (OTHER).
Who is sponsoring clinical trial NCT01084135?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01084135's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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