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Sleep Aging and Risk for Alzheimer's 2.0 (SARA)

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ClinicalTrials.gov Identifier: NCT03278119
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment
Alzheimer Disease Sleep Apnea Diagnostic Test: PET Scan and nocturnal polysomnography

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Study Type : Observational
Estimated Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Aging and Risk for Alzheimer's Resubmission 2.0
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
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
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
Diagnostic Test: 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




Primary Outcome Measures :
  1. Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD. [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Establishing that SWS quality is associated with longitudinal amyloid deposition will identify a key mechanism by which age increases AD risk. [ Time Frame: 2.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
112 subjects with normal sleep breathing (non-OSA) or mild to moderate OSA (AHI4%<30).
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 both a CDR=0 and a MMSE>26.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278119


Contacts
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Contact: Ricardo Osorio, M.D 212-263-3255 ricardo.osorio@nyumc.org
Contact: Margo Miller 212-263-7795 margo.miller@nyumc.org

Locations
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United States, New York
NYU Center for Brain Health Recruiting
New York, New York, United States, 10016
Contact: Ricardo Osorio, M.D    212-263-3255    Ricardo.Osorio@nyumc.org   
Contact: Margo Miller, Bachelors    212-263-7795    Margo.Miller@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Ricardo Osorio, MD New York Langone Medical Center

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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03278119     History of Changes
Other Study ID Numbers: 17-01005
R01AG056031 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders