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

NCT ID: NCT03912571

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-13

Study Completion Date

2019-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Sleep Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild Cognitive Impairment (MCI)

Patients with clinical dementia rating of 0.5 or a global deterioration scale of 3.

VR-CO2 MRI Scans

Intervention Type DIAGNOSTIC_TEST

reduced vaso reactivity to carbon dioxide

Structural 3T MRI

Intervention Type DIAGNOSTIC_TEST

measures of global and hippocampal atrophy)

MRI Based Perfusion Imaging

Intervention Type DIAGNOSTIC_TEST

brain blood flow

Normal Cognition (NL)

Clinical Dementia Rating \[CDR\] of 0 or Global Deterioration Scale \[GDS\] of 1-2

VR-CO2 MRI Scans

Intervention Type DIAGNOSTIC_TEST

reduced vaso reactivity to carbon dioxide

Structural 3T MRI

Intervention Type DIAGNOSTIC_TEST

measures of global and hippocampal atrophy)

MRI Based Perfusion Imaging

Intervention Type DIAGNOSTIC_TEST

brain blood flow

Interventions

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VR-CO2 MRI Scans

reduced vaso reactivity to carbon dioxide

Intervention Type DIAGNOSTIC_TEST

Structural 3T MRI

measures of global and hippocampal atrophy)

Intervention Type DIAGNOSTIC_TEST

MRI Based Perfusion Imaging

brain blood flow

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Osorio, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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12-00041

Identifier Type: -

Identifier Source: org_study_id

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