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

September 2, 2021 updated by: NYU Langone Health
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

80 cognitively healthy subjects (normal or MCI) previously enrolled in Alzheimer's Disease Core Center (ADCC) and CBH studies who have agreed to be contacted about future research studies will be asked to additionally participate in this study. The age range of the subjects will be of 55-90 years based on the incidence of dementia in middle age and elder adults.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased cerebral blood flow (CBF)
Time Frame: 1 Week
Measured by perfusion MRI
1 Week
Measure of vasoreactivity to CO2 (VRCO2)
Time Frame: 1 Week
subjects will breath through a respiratory tube and CO2 will be meaured
1 Week
Increase in cortical AB plaque burden
Time Frame: 1 Week
Measured by PIB PET
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Ricardo Osorio, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2011

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-00041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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