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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912571
• Other study ID #: 12-00041
• Status: Completed
• Start date: November 13, 2011
• Est. completion date: September 2019

Study information

• Verified date: September 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• Structural 3T MRI
measures of global and hippocampal atrophy)
• MRI Based Perfusion Imaging
brain blood flow
• VR-CO2 MRI Scans
reduced vaso reactivity to carbon dioxide

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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