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NCT00706186 · ClinicalTrials.gov registry record · Phase 4
Safety and Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients
A Phase 4 study, sponsored by Clayton Sleep Insititute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT00706186 is a Phase 4 study that was terminated before completion, run by Clayton Sleep Insititute. The registered enrollment target is 4 participants.
The verdict
NCT00706186, a Phase 4 study, was terminated before completion, sponsored by Clayton Sleep Insititute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
Eligible patients will undergo this open label initial safety and feasibility study investigating the use of 6 g/day sodium oxybate in mild AD. A total of 5 visits are included with this trial and total subject participation duration of 7-8 weeks. The screening phase will include an initial screening visit and a screening PSG night. After successful screening, subjects will complete a baseline PSG night and undergo a third PSG night to monitor initial safety and compliance with study drug at a dosage of 4.5 g/day of sodium oxybate. Thus the subject will undergo three consecutive nights of PSG in the sleep center. The patient will maintain a dosage of 4.5 g/day for a duration of 7 days leading to Treatment Visit 1. After successful assessment at Treatment Visit 1, the dosage will be increased to 6 g/day for the duration of the trial. At Treatment Visit 2 (day 21), the dosage will be increased to a dosage of 9 g/day, if tolerated by the patient. The remaining visit will occur at 6 weeks after baseline, with Treatment Visit 3 consisting of two consecutive nights of PSG. Participation will be complete after this visit. Phone follow-up will be made at one week post completion visits to assess any wash-out symptoms. Please refer to Figure for flow of the study design.
Interventions
- DRUG Sodium Oxybate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00706186
The ClinicalTrials.gov registry entry for NCT00706186 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clayton Sleep Insititute, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sodium Oxybate is the first listed.
NCT00706186 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00706186 about?
NCT00706186 is a clinical study titled "Safety and Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients". Eligible patients will undergo this open label initial safety and feasibility study investigating the use of 6 g/day sodium oxybate in mild AD. A total of 5 visits are included with this trial and total subject participation duration of 7-8 weeks. The screening phase will include an initial screenin...
What is the current status of trial NCT00706186?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants.
What interventions are being tested in trial NCT00706186?
The interventions under investigation include: Sodium Oxybate (DRUG).
Who is sponsoring clinical trial NCT00706186?
This trial is sponsored by Clayton Sleep Insititute, which has 3 total clinical trials registered on ClinicalTrials.gov.
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