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

Completed

• Conditions: Sleep Disorder
• Interventions: Diagnostic Test: Structural 3T MRI; Diagnostic Test: MRI Based Perfusion Imaging; Diagnostic Test: VR-CO2 MRI Scans

• Registration Number: NCT03912571
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-11-13
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Cognition (NL)	VR-CO2 MRI Scans	Clinical Dementia Rating \[CDR\] of 0 or Global Deterioration Scale \[GDS\] of 1-2
Mild Cognitive Impairment (MCI)	MRI Based Perfusion Imaging	Patients with clinical dementia rating of 0.5 or a global deterioration scale of 3.
Normal Cognition (NL)	MRI Based Perfusion Imaging	Clinical Dementia Rating \[CDR\] of 0 or Global Deterioration Scale \[GDS\] of 1-2
Mild Cognitive Impairment (MCI)	VR-CO2 MRI Scans	Patients with clinical dementia rating of 0.5 or a global deterioration scale of 3.
Normal Cognition (NL)	Structural 3T MRI	Clinical Dementia Rating \[CDR\] of 0 or Global Deterioration Scale \[GDS\] of 1-2
Mild Cognitive Impairment (MCI)	Structural 3T MRI	Patients with clinical dementia rating of 0.5 or a global deterioration scale of 3.

Primary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States