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NCT02474251 · ClinicalTrials.gov registry record · NA
Brain Sleep Clearance of Amyloid-Beta Peptides
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT02474251 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 38 participants.
The verdict
NCT02474251, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
The 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta (Aβ), in the brain is the initiating event in Alzheimer's disease (AD), however, the mechanisms involved are not well understood. Recent studies support the hypothesis that Aβ dynamics in the brain are influenced by the sleep-wake cycle, with increases in the production of soluble Aβ during wakefulness and decreases during non-rapid eye movement (NREM) sleep, and more specifically on NREM stage 3 (also called slow wave sleep \[SWS\]). These changes produce a consistent diurnal pattern in the cerebrospinal fluid (CSF) that has been documented in murine models and in humans. By better understanding this sleep-wake relationship the investigators hope to identify how sleep disorders accelerate the progression of AD in the elderly (which has been demonstrated by multiple epidemiological studies) and, in turn, identify novel therapeutic targets for AD prevention. The purpose of this study is to elucidate how soluble amyloid beta (Aβ) levels in the brain are influenced by the sleep-wake cycle in humans, and to test the directionality of this relationship through sleep disruption experiments. The investigators will test two models. The first model will test how, prior to amyloid deposition, brain soluble Aβ levels may be relatively increased in the elderly by two mechanisms: a) loss of total sleep time and SWS that occur with normal aging; and b) sleep disturbances such as Sleep Disordered Breathing (SDB) or insomnia that are common in late life (Aim 1). The second model will test how stage-specific sleep disruption may lead to increased CSF Aβ42 levels (Aim 2). A group of adults with diagnosed severe SDB and good continuous positive airway pressure (CPAP) compliance will be used to test this model sleep deprivation experiments using therapeutic CPAP vs. sham CPAP. This project will be the first to explore the protective effect of SWS on Aβ42 dynamics in a group of cognitively normal
Interventions
- OTHER Continuous positive airway pressure device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-10-01 |
| Est. Completion | 2019-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02474251
The ClinicalTrials.gov registry entry for NCT02474251 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Continuous positive airway pressure device is the first listed.
NCT02474251 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02474251 about?
NCT02474251 is a clinical study titled "Brain Sleep Clearance of Amyloid-Beta Peptides". The 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta (Aβ), in the brain is the initiating event in Alzheimer's disease (AD), however, the mechanisms involved are not well understood. Recent studies support the hypothesis that Aβ dynamics in the brain are influence...
What is the current status of trial NCT02474251?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2015-10-01. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT02474251?
The interventions under investigation include: Continuous positive airway pressure device (OTHER).
Who is sponsoring clinical trial NCT02474251?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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