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Completed

NCT Number: NCT03912571

Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment

The purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation in the Following studies 'Alzheimer's Disease Core Center (ADCC) Clinical Evaluation' (IRB: 2942), MRI Progression Markers of Cognitive Decline in the Elderly' (IRB:09-0586), or 'Imaging Neuro inflammation in Alzheimer's Disease with [11C] Arachidonic Acid (AA) and PET'(IRB: 10-00442).

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Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects will have participated in prior CBH studies and have agreed to an FDG, PIB and MRI scans.

Exclusion criteria

  • Diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (CPAP) machine.
  • Active depressive episode during the evaluation with a Geriatric Depression Scale score >7 and/or a Clinical Global Impression scale for depression score >4.
  • Moderate Cognitive decline (GDS >3).
  • Severe primary or secondary insomnia except insomnia due to SDB.

Treatment and study plan

Structural 3T MRI

Diagnostic Test

measures of global and hippocampal atrophy)

MRI Based Perfusion Imaging

Diagnostic Test

brain blood flow

VR-CO2 MRI Scans

Diagnostic Test

reduced vaso reactivity to carbon dioxide

Primary outcomes

  1. Decreased cerebral blood flow (CBF)

    Time frame: 1 Week

    Measured by perfusion MRI

  2. Measure of vasoreactivity to CO2 (VRCO2)

    Time frame: 1 Week

    subjects will breath through a respiratory tube and CO2 will be meaured

  3. Increase in cortical AB plaque burden

    Time frame: 1 Week

    Measured by PIB PET

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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