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NCT01778946 · ClinicalTrials.gov registry record · Phase 1
Nicotine Treatment of Cognitive Decline in Down Syndrome
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01778946 is a Phase 1 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 7 participants.
The verdict
NCT01778946, a Phase 1 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study will ascertain whether nicotine is safe and tolerable in DS patients, help with dose-ranging of nicotine in DS, look for evidence of enhancements in cognitive functioning, and establish evidence for biological and behavioral correlates of nicotinic stimulation effects. The knowledge gained from the translational aspects of this project may also guide the application of new nicotinic drugs in DS and generate, for the first time, data on the importance of nicotinic receptor changes in the development of cognitive impairment in DS adults. Hypotheses: * Transdermal nicotine treatment will be well tolerated out to one month by non-smoking DS patients without significant adverse effects. * Nicotine will enhance cognitive performance by one month compared to baseline and post-treatment testing. * Nicotine will enhance functioning detectable by clinician and/or informant ratings (pre-post).
Interventions
- DRUG Low Dose Nicotine (7mg)
- DRUG Moderate Dose Nicotine (14mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2013-04 |
| Est. Completion | 2021-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01778946
The ClinicalTrials.gov registry entry for NCT01778946 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low Dose Nicotine (7mg) is the first listed.
NCT01778946 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01778946 about?
NCT01778946 is a clinical study titled "Nicotine Treatment of Cognitive Decline in Down Syndrome". This study will ascertain whether nicotine is safe and tolerable in DS patients, help with dose-ranging of nicotine in DS, look for evidence of enhancements in cognitive functioning, and establish evidence for biological and behavioral correlates of nicotinic stimulation effects. The knowledge gaine...
What is the current status of trial NCT01778946?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2013-04. Estimated completion is 2021-02.
What interventions are being tested in trial NCT01778946?
The interventions under investigation include: Low Dose Nicotine (7mg) (DRUG), Moderate Dose Nicotine (14mg) (DRUG).
Who is sponsoring clinical trial NCT01778946?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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