Sleep Aging and Risk for Alzheimer's 2.0

NCT ID: NCT03278119

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2025-12-25

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

PET Scan and nocturnal polysomnography

Intervention Type: 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

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

PET Scan and nocturnal polysomnography

Intervention Type: 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

Interventions

PET Scan and nocturnal polysomnography

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

Intervention Type: DIAGNOSTIC_TEST

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=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.

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)>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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo Osorio, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

Healthy Brain Aging and Sleep Center

New York, New York, United States

Countries

United States

Other Identifiers

R01AG056031

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-01005

Identifier Type: -

Identifier Source: org_study_id