<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278119</url>
  </required_header>
  <id_info>
    <org_study_id>17-01005</org_study_id>
    <secondary_id>R01AG056031</secondary_id>
    <nct_id>NCT03278119</nct_id>
  </id_info>
  <brief_title>Sleep Aging and Risk for Alzheimer's 2.0</brief_title>
  <acronym>SARA</acronym>
  <official_title>Sleep Aging and Risk for Alzheimer's Resubmission 2.0</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Age-related sleep changes and common sleep disorders like obstructive sleep apnea (OSA) may&#xD;
      increase amyloid burden and represent risk factors for cognitive decline in the elderly. We&#xD;
      will directly interrogate the brain using a 2-night nocturnal polysomnography (NPSG) and&#xD;
      amyloid deposition using C-PiB PET/MR both at baseline and at the 24-month follow-up. This&#xD;
      study has the potential to identify the mechanisms by which age-related sleep changes&#xD;
      contribute to AD neurodegeneration in cognitively normal elderly, the group that could profit&#xD;
      the most from sleep preventive strategies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">May 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.</measure>
    <time_frame>2.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Establishing that SWS quality is associated with longitudinal amyloid deposition will identify a key mechanism by which age increases AD risk.</measure>
    <time_frame>2.5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Sleep Apnea</arm_group_label>
    <description>Overall 56&#xD;
both male and female&#xD;
age group 55 to 75 years, having mild to severe obstructive sleep apnea&#xD;
in good general health with no significant comorbidities&#xD;
Located for the most part in boroughs of New York City</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Sleep Apnea</arm_group_label>
    <description>Overall 56&#xD;
both male and female&#xD;
age group 55 to 75 years, without OSA&#xD;
in good general health with no significant comorbidities&#xD;
Located for the most part in boroughs of New York City</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PET Scan and nocturnal polysomnography</intervention_name>
    <description>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</description>
    <arm_group_label>No Sleep Apnea</arm_group_label>
    <arm_group_label>Sleep Apnea</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        112 subjects with normal sleep breathing (non-OSA) or mild to moderate OSA (AHI4%&lt;30).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible to participate in this study, an individual must meet all of the following&#xD;
        criteria:&#xD;
&#xD;
          -  Male and female subjects with normal cognition and 55-75 years.&#xD;
&#xD;
          -  Within normal limits on neurological and psychiatric examinations. All subjects&#xD;
             enrolled will have a CDR=0.&#xD;
&#xD;
          -  All subjects will have had a minimum of 12 years of education. Among minority subjects&#xD;
             &gt;80% of the elderly individuals coming to the NYU-ADC meet this criterion. The&#xD;
             education restriction reduces performance variance on cognitive test measures and&#xD;
             improves the sensitivity for detecting pathology and disease progression using the&#xD;
             robust norms available at NYU. Given most subjects will meet this criterion we do not&#xD;
             consider this a major selection bias or generalization limitation for this study.&#xD;
&#xD;
          -  An informed family member or life-partner (preferably bed-partner) will be interviewed&#xD;
             to confirm the reliability of the subject interview.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          -  History of brain tumor, MRI evidence of brain damage or brain disease including&#xD;
             significant trauma, hydrocephalus, seizures, mental retardation or other serious&#xD;
             neurological disorder (e.g. Parkinson's disease or other movement disorders).&#xD;
&#xD;
          -  Significant history of alcoholism or drug abuse.&#xD;
&#xD;
          -  History of psychiatric illness (e.g., schizophrenia, bipolar, PTSD, or life-long&#xD;
             history of major depression).&#xD;
&#xD;
          -  Geriatric Depression Scale (short form)&gt;6.&#xD;
&#xD;
          -  Insulin dependent diabetes.&#xD;
&#xD;
          -  Evidence of clinically relevant cardiac, pulmonary, endocrine or hematological&#xD;
             conditions.&#xD;
&#xD;
          -  Physical impairment of such severity as to adversely affect the validity of&#xD;
             psychological testing.&#xD;
&#xD;
          -  Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard&#xD;
             for MRI imaging.&#xD;
&#xD;
          -  Medications affecting cognition: Narcotic analgesics, chronic use of medications with&#xD;
             anticholinergic activity, anti-Parkinsonian medications (carbidopa/levodopa,&#xD;
             amantadine, bromocriptine, selegiline). Others: amphetamines, amphetamine-like&#xD;
             compounds, appetite suppressants, phenothiazines, reserpine, buspirone, clonidine,&#xD;
             disulfiram, guanethidine, MAO inhibitors, theophylline, tricyclic antidepressants,&#xD;
             salicylates, cholinesterase inhibitors and memantine.&#xD;
&#xD;
          -  History of a first-degree family member with early onset (age &lt;60 years) dementia.&#xD;
&#xD;
          -  Irregular sleep-wake rhythms (based on the actigraphy recordings) or severe OSA&#xD;
             (AHI4%≥30).&#xD;
&#xD;
          -  Chronic use of antidepressants and melatonin are allowed.&#xD;
&#xD;
          -  Excessive daytimes sleepiness (Epworth Sleepiness Scale &gt;10) or history of CVE&#xD;
             (arrhythmias, heart valve disease, cardiomyopathy, carotid or coronary artery disease&#xD;
             and chest pain) will not be allowed in the OSA groups.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Osorio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Langone Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gabriela Silva Albornoz</last_name>
    <phone>2122635053</phone>
    <email>Gabriela.SilvaAlbornoz@nyulangone.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Courtney O'Brien</last_name>
    <phone>(646) 754-2235</phone>
    <email>courtney.o'brien@nyulangone.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Healthy Brain Aging and Sleep Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ricardo Osorio, M.D</last_name>
      <phone>212-263-3255</phone>
      <email>Ricardo.Osorio@nyulangone.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278119
org study id: 17-01005
secondary id: R01AG056031
nct id: NCT03278119
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Establishing how mild-to-moderate OSA increases AD risk will inform novel preventive therapies for AD.
time frame: 2.5 years
measure: 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
arm group label: Sleep Apnea
description: 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
arm group label: No Sleep Apnea
description: 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 type: Diagnostic Test
intervention name: PET Scan and nocturnal polysomnography
description: 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
arm group label: No Sleep Apnea
arm group label: Sleep Apnea
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ricardo Osorio, MD
role: Principal Investigator
affiliation: New York Langone Medical Center
last name: Gabriela Silva Albornoz
phone: 2122635053
email: Gabriela.SilvaAlbornoz@nyulangone.org
last name: Courtney O'Brien
phone: (646) 754-2235
email: courtney.o'brien@nyulangone.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: Undecided