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

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ClinicalTrials.gov Identifier: NCT03912571
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Sleep Disorder Diagnostic Test: Structural 3T MRI Diagnostic Test: MRI Based Perfusion Imaging Diagnostic Test: VR-CO2 MRI Scans Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment
Actual Study Start Date : November 13, 2011
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mild Cognitive Impairment (MCI)
Patients with clinical dementia rating of 0.5 or a global deterioration scale of 3.
Diagnostic Test: Structural 3T MRI
measures of global and hippocampal atrophy)

Diagnostic Test: MRI Based Perfusion Imaging
brain blood flow

Diagnostic Test: VR-CO2 MRI Scans
reduced vaso reactivity to carbon dioxide

Active Comparator: Normal Cognition (NL)
Clinical Dementia Rating [CDR] of 0 or Global Deterioration Scale [GDS] of 1-2
Diagnostic Test: Structural 3T MRI
measures of global and hippocampal atrophy)

Diagnostic Test: MRI Based Perfusion Imaging
brain blood flow

Diagnostic Test: VR-CO2 MRI Scans
reduced vaso reactivity to carbon dioxide




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912571


Contacts
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Contact: Margo Miller, MD (212) 263-7795 Margo.Miller@nyulangone.org

Locations
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United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Margo Miller, MD    212-263-7795    Margo.Miller@nyumc.org   
Principal Investigator: Ricardo Osorio, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Ricardo Osorio, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03912571     History of Changes
Other Study ID Numbers: 12-00041
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Alzheimer Disease
Sleep Wake Disorders
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Signs and Symptoms
Apnea
Sleep Disorders, Intrinsic
Dyssomnias