Sleep Aging and Risk for Alzheimer's 2.0

NCT03278119 | Active Not Recruiting DMC

• 2 other identifiers: 17-01005R01AG056031
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

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

  2.5 years

Secondary Outcomes (1)

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

  2.5 years

Study Arms (2)

Sleep Apnea

Overall 56 * both male and female * age group 55 to 75 years, having mild to severe obstructive sleep apnea * in good general health with no significant comorbidities * Located for the most part in boroughs of New York City

Diagnostic Test: PET Scan and nocturnal polysomnography

No Sleep Apnea

Overall 56 * both male and female * age group 55 to 75 years, without OSA * in good general health with no significant comorbidities * Located for the most part in boroughs of New York City

Diagnostic Test: PET Scan and nocturnal polysomnography

Interventions

PET Scan and nocturnal polysomnography DIAGNOSTIC_TEST

Amyloid PET scans will be used to assess amyloid burden in the brain, and nocturnal polysomnography will be used to assess sleep and cardiopulmonary variables

No Sleep Apnea; Sleep Apnea

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

112 subjects with normal sleep breathing (non-OSA) or mild to moderate OSA (AHI4%\<30).

You may qualify if:

• 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=0.
• 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.

You may not qualify if:

• 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)\>6.
• 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.
• History of a first-degree family member with early onset (age \<60 years) dementia.
• Irregular sleep-wake rhythms (based on the actigraphy recordings) or severe OSA (AHI4%≥30).
• Chronic use of antidepressants and melatonin are allowed.
• Excessive daytimes sleepiness (Epworth Sleepiness Scale \>10) or history of CVE (arrhythmias, heart valve disease, cardiomyopathy, carotid or coronary artery disease and chest pain) will not be allowed in the OSA groups.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Healthy Brain Aging and Sleep Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Sleep Apnea Syndromes

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Ricardo Osorio, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 11, 2017
• Study Start: May 1, 2018
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)