Sleep Aging and Risk for Alzheimer's Resubmission 2.0

NYU Langone Health1 site in 1 country158 target enrollmentMay 1, 2018

ConditionsAlzheimer Disease Sleep Apnea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alzheimer Disease
Sponsor: NYU Langone Health
Enrollment: 158
Locations: 1
Primary Endpoint: Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Age-related sleep changes and common sleep disorders like obstructive sleep apnea (OSA) may increase amyloid burden and represent risk factors for cognitive decline in the elderly. We will directly interrogate the brain using a 2-night nocturnal polysomnography (NPSG) and amyloid deposition using C-PiB PET/MR both at baseline and at the 24-month follow-up. This study has the potential to identify the mechanisms by which age-related sleep changes contribute to AD neurodegeneration in cognitively normal elderly, the group that could profit the most from sleep preventive strategies.

Registry

clinicaltrials.gov

Start Date

May 1, 2018

End Date

December 25, 2025

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

NYU Langone Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•To be eligible to participate in this study, an individual must meet all of the following criteria:
•Male and female subjects with normal cognition and 55-75 years.
•Within normal limits on neurological and psychiatric examinations. All subjects enrolled will have a CDR=
•All subjects will have had a minimum of 12 years of education. Among minority subjects \>80% of the elderly individuals coming to the NYU-ADC meet this criterion. The education restriction reduces performance variance on cognitive test measures and improves the sensitivity for detecting pathology and disease progression using the robust norms available at NYU. Given most subjects will meet this criterion we do not consider this a major selection bias or generalization limitation for this study.
•An informed family member or life-partner (preferably bed-partner) will be interviewed to confirm the reliability of the subject interview.

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders).
•Significant history of alcoholism or drug abuse.
•History of psychiatric illness (e.g., schizophrenia, bipolar, PTSD, or life-long history of major depression).
•Geriatric Depression Scale (short form)\>
•Insulin dependent diabetes.
•Evidence of clinically relevant cardiac, pulmonary, endocrine or hematological conditions.
•Physical impairment of such severity as to adversely affect the validity of psychological testing.
•Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
•Medications affecting cognition: Narcotic analgesics, chronic use of medications with anticholinergic activity, anti-Parkinsonian medications (carbidopa/levodopa, amantadine, bromocriptine, selegiline). Others: amphetamines, amphetamine-like compounds, appetite suppressants, phenothiazines, reserpine, buspirone, clonidine, disulfiram, guanethidine, MAO inhibitors, theophylline, tricyclic antidepressants, salicylates, cholinesterase inhibitors and memantine.

Outcomes

Primary Outcomes

Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.

Time Frame: 2.5 years

Secondary Outcomes

Establishing that SWS quality is associated with longitudinal amyloid deposition will identify a key mechanism by which age increases AD risk.(2.5 years)