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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: Clinical Trial Phase 4 study, sponsored by Clayton Sleep Insititute.
NCT00706186 is a Phase 4 study that was terminated before completion, run by Clayton Sleep Insititute. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00706186 stopped before completion
NCT00706186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium Oxybate is the first listed.
NCT00706186 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00706186's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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