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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):
NYU Langone Health

Tracking Information
First Submitted Date September 7, 2017
First Posted Date September 11, 2017
Last Update Posted Date March 19, 2019
Actual Study Start Date May 1, 2018
Estimated Primary Completion Date May 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2017)
Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD. [ Time Frame: 2.5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03278119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 7, 2017)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sleep Aging and Risk for Alzheimer's 2.0
Official Title Sleep Aging and Risk for Alzheimer's Resubmission 2.0
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 112 subjects with normal sleep breathing (non-OSA) or mild to moderate OSA (AHI4%<30).
Condition
  • Alzheimer Disease
  • Sleep Apnea
Intervention 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
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Diagnostic Test: PET Scan and nocturnal polysomnography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 7, 2017)
124
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 30, 2023
Estimated Primary Completion Date May 30, 2023   (Final data collection date for primary outcome measure)
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 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ricardo Osorio, M.D 212-263-3255 ricardo.osorio@nyumc.org
Contact: Margo Miller 212-263-7795 margo.miller@nyumc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03278119
Other Study ID Numbers 17-01005
R01AG056031 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators National Institute on Aging (NIA)
Investigators
Principal Investigator: Ricardo Osorio, MD New York Langone Medical Center
PRS Account NYU Langone Health
Verification Date March 2019