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NCT01962779: SARA

Sleep, Aging and Risk for Alzheimer's Disease

Completed NA Last updated 21 July 2020
What this trial tests

NA trial testing Continuous positive airway pressure (CPAP) in Sleep Disordered Breathing in 235 participants. Completed in 3 May 2017.

Timeline
31 July 2013
Primary endpoint
3 May 2017
3 May 2017

Quick facts

Lead sponsorNYU Langone Health
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment235
Start date31 July 2013
Primary completion3 May 2017
Estimated completion3 May 2017
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

NYU Langone Health — full company profile →

Who can join

50 and older, any sex, with Sleep Disordered Breathing or Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Our preliminary data show for in cognitively-normal elderly, that Sleep Disordered Breathing (SDB) is associated with the increase of cerebrospinal fluid (CSF) phosphorylated-Tau (P-Tau) and total-Tau (T-Tau), decreases in medial temporal lobe glucose uptake (FDG-PET) and volume (MRI) and progressive memory decline, all of which have been shown to be useful in predicting future dementia in older adults. These findings raise the question as to whether Alzheimer's disease (AD) tissue damage causes SDB in the elderly, or alternatively, if SDB acts as a risk factor for AD neurodegeneration. In the proposed study, we will investigate these mechanistic hypotheses in cognitively normal elderly by examining the longitudinal associations between SDB and cognitive decline, novel MR neuroimaging and CSF biomarkers for neurodegeneration; while our secondary goal is to launch a pilot treatment study to aid in interpreting the mechanistic hypotheses and to examine the effects of nasal continuous positive airway pressure (CPAP) on cognitive decline and neurodegeneration.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Orexin-A is Associated with Increases in Cerebrospinal Fluid Phosphorylated-Tau in Cognitively Normal Elderly Subjects.
    Osorio RS, Ducca EL, Wohlleber ME, Tanzi EB, et al · · 2016 · cited 44× · PMID 26951396 · DOI 10.5665/sleep.5846
  2. Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
    Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
  3. Interaction between therapeutic interventions for Alzheimer's disease and physiological Aβ clearance mechanisms.
    Morrone CD, Liu M, Black SE, McLaurin J. · · 2015 · cited 23× · PMID 25999850 · DOI 10.3389/fnagi.2015.00064

Verify or expand the search:

Other trials of Continuous positive airway pressure (CPAP)

Trials testing the same drug.

Other recruiting trials for Sleep Disordered Breathing

Currently open trials in the same condition.

Other NYU Langone Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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