drugset / Trial / NCT02063217
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Completed
36 enrolled
Washington University School of Medicine
National Institute on Aging (NIA) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupSingle-blindOther
Summary
The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.
Timeline
- Start
- 2013-12
- Primary completion
- 2016-07
- Completion
- 2016-07
Outcome
Missed primary endpoint
registry analysis (superiority test); Sleep Deprivation vs Control; p = 0.07; Mean Difference (Net) 17 NCT02063217 ↗
registry analysis (superiority test); Sleep Induction vs Control; p = 1.0; Mean Difference (Net) 7 NCT02063217 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Oxybate | Unknown | 7.5 g | — |
Indications
No indication recorded.