<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/NCT03814603</url>
  </required_header>
  <id_info>
    <org_study_id>s18-01302</org_study_id>
    <nct_id>NCT03814603</nct_id>
  </id_info>
  <brief_title>The Sleep Amyloid, Slow WAve Race and Ethnicity Study</brief_title>
  <acronym>Sleep AWARE</acronym>
  <official_title>A Single-center, Observational, Longitudinal Study on the Effect of Slow Wave Sleep (SWS) Characteristics and Race and Ethnicity on Amyloid Burden (a Marker of Alzheimer's Disease Risk), Among Cognitively Normal Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      African-Americans (AAs) have an increased prevalence of both Alzheimer's disease (AD) and&#xD;
      vascular risk factors for AD such as diabetes and hypertension when compared to whites.&#xD;
      However, in a recent community based study of non-demented elderly, black race was associated&#xD;
      with higher amyloid burden after adjusting for vascular risk factors, suggesting the presence&#xD;
      of additional physiological differences on AD-risk by race in the early stages of the&#xD;
      disease. The purpose of this study is to test whether poor slow wave sleep (SWS) quantity&#xD;
      (SWS duration) and quality (slow wave activity, SWA) is one of these physiological factors.&#xD;
      To test these hypotheses, the investigators will perform community outreach in churches and&#xD;
      community-based organizations in Brooklyn and other NYC boroughs with which we have created&#xD;
      substantial ties in recent years. In consultation with community stakeholders, the&#xD;
      investigators will recruit 150 cognitively normal AA elderly (age 60-75) and 60 age, sex,&#xD;
      BMI, income and education matched non-Hispanic whites from the same geographical areas.&#xD;
      Investigators will first perform a medical and cognitive evaluation (Visit 1). Participants&#xD;
      will then undergo 2 nights of home sleep monitoring using an unattended device to exclude&#xD;
      OSA, followed by 7 days of actigraphy with a sleep log to record sleep duration. Both devices&#xD;
      will be returned by mail. Subjects with reported total sleep time (TST) between 5 and 10&#xD;
      hours and absence of moderate to severe OSA will be invited to perform a 2-night nocturnal&#xD;
      polysomnography (NPSG) (Nights 1-2) and a PiB-PET MR scan (Visit 2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Association between Percentage of African Ancestry (%AF) and Slow Wave Sleep (SWS) duration and activity (SWA).</measure>
    <time_frame>Determined at baseline.</time_frame>
    <description>Aim 1 will test if individual % African ancestry (%AF), estimated from 0-100 and computed using a maximum likelihood method for inferring individual admixture based upon allele frequencies ascertained from Utah residents with Northern and Western European ancestry and West African samples, is associated with short SWS duration/ and poor slow wave activity (SWA), determined through polysomnography, in older AAs while controlling for other moderating factors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine association between SWS duration and poor SWA with longitudinal change in amyloid burden.</measure>
    <time_frame>Baseline and 2.5 year follow-up</time_frame>
    <description>Aim 2 will test the effect of race and its interaction with baseline SWS duration and SWA with amyloid plaque burden both at baseline and follow-up by determining mean PiB standard uptake value using PET-MR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the association between race, SWS duration and poor SWA and cognition using both standardized and sleep-dependent cognitive tests at baseline and follow-up.</measure>
    <time_frame>Baseline and 2.5 year follow-up</time_frame>
    <description>Aim 3 will test the effect of race and baseline SWS duration and poor SWA on overall cognition using standardized and sleep-dependent tests: the UDS 3.0, WHICAP Clinical Core Neuropsychological test battery, as well as a 3-D Virtual Maze Task, both at baseline and follow-up.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>African Americans</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Hispanic Whites</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PET-MR Scan</intervention_name>
    <description>Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.</description>
    <arm_group_label>African Americans</arm_group_label>
    <arm_group_label>Non-Hispanic Whites</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PiB</intervention_name>
    <description>Subjects will receive a single dose of 555 MBq of PiB and perform a dynamic 30 min PiB PET-MR scan 60 min after injection.</description>
    <arm_group_label>African Americans</arm_group_label>
    <arm_group_label>Non-Hispanic Whites</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood will be drawn for clinical labs and to obtain DNA for ApoE genotyping.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        210 cognitively normal elderly (Clinical Dementia Rating [CDR]=0), self-identified as&#xD;
        African-American (AA) or non-Hispanic white (NHW), ages 60 to 75 years, with English as&#xD;
        their primary language&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects with normal cognition and ages 60 to 75.&#xD;
&#xD;
          -  Within normal limits on neurological and psychiatric examinations. All subjects&#xD;
             enrolled will have a CDR=0.&#xD;
&#xD;
          -  An informed family member or life-partner (preferably bed-partner) will be interviewed&#xD;
             over the phone or on the first or second visit to confirm the reliability of the&#xD;
             subject interview. A study partner is preferably a spouse, close friend, or relative.&#xD;
&#xD;
          -  Self-identified as African-American Black or non-Hispanic white.&#xD;
&#xD;
          -  All subjects must sign the Alzheimer's Disease Center consent form&#xD;
&#xD;
        Exclusion Criteria:&#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 based off of the CAGE questionnaire (&gt;2) or drug&#xD;
             abuse.&#xD;
&#xD;
          -  History of psychiatric illness (e.g., schizophrenia, bipolar or PTSD)&#xD;
&#xD;
          -  Lifelong depression and anxiety will be allowed as long as there has been no active&#xD;
             depressive episode within the last two years.&#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 based off of the PI's discretion.&#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 or SWS:&#xD;
&#xD;
               -  Narcotic analgesics.&#xD;
&#xD;
               -  Chronic use of medications with anticholinergic activity.&#xD;
&#xD;
               -  Anti-Parkinsonian medications (carbidopa/levodopa, amantadine, bromocriptine,&#xD;
                  pergolide, selegiline).&#xD;
&#xD;
               -  Others: amphetamines, amphetamine-like compounds, appetite suppressants,&#xD;
                  phenothiazines, reserpine, buspirone, clonidine, disulfiram, guanethidine, MAO&#xD;
                  inhibitors, theophylline, tricyclic antidepressants, gabapentin, pregabalin,&#xD;
                  trazodone, cholinesterase inhibitors, memantine.&#xD;
&#xD;
          -  Chronic use of antidepressants are allowed.&#xD;
&#xD;
          -  History of a first-degree family member with early onset (age &lt;60 years) dementia.&#xD;
&#xD;
          -  Short sleepers (&lt; 5 hours a day) and long sleepers (&gt; 10 hours a day).&#xD;
&#xD;
          -  OSA (defined as AHI4%&gt;15 and AHI4%&gt;5 with Epworth≥10)&#xD;
&#xD;
          -  Self-identified as US-born Caribbean Black, Caribbean-born Black or African-born&#xD;
             Black.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 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>NYU Department of Psychiatry</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Payton White</last_name>
    <phone>212-263-7795</phone>
    <email>Payton.white@nyulangone.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>NYU Center for Brain Health</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>Dishari Azad</last_name>
      <phone>646-754-2229</phone>
      <email>Dishari.azad@nyulangone.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 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>Yes</sharing_ipd>
    <ipd_description>Subjects will have the option to allow their leftover blood and DNA samples to be banked indefinitely for future research related to studies on early diagnosis of Alzheimer's, disease and/or mechanism of neurodegeneration. After the study is completed, the de-identified, archived data will be transmitted to and stored at the CBH Biorepository, under the supervision of Dr. Osorio, for use by other researchers including those outside of the study. Permission to transmit data to the CBH Biorepository will be included in the ICF. During the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens stored for future research. However, withdrawal of consent with regard to biosample storage will not be possible after the study is completed. When the study is completed, access to study data and/or samples will be provided through the CBH Biorepository.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03814603/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03814603
org study id: s18-01302
nct id: NCT03814603
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
African-Americans (AAs) have an increased prevalence of both Alzheimer's disease (AD) and
      vascular risk factors for AD such as diabetes and hypertension when compared to whites.
      However, in a recent community based study of non-demented elderly, black race was associated
      with higher amyloid burden after adjusting for vascular risk factors, suggesting the presence
      of additional physiological differences on AD-risk by race in the early stages of the
      disease. The purpose of this study is to test whether poor slow wave sleep (SWS) quantity
      (SWS duration) and quality (slow wave activity, SWA) is one of these physiological factors.
      To test these hypotheses, the investigators will perform community outreach in churches and
      community-based organizations in Brooklyn and other NYC boroughs with which we have created
      substantial ties in recent years. In consultation with community stakeholders, the
      investigators will recruit 150 cognitively normal AA elderly (age 60-75) and 60 age, sex,
      BMI, income and education matched non-Hispanic whites from the same geographical areas.
      Investigators will first perform a medical and cognitive evaluation (Visit 1). Participants
      will then undergo 2 nights of home sleep monitoring using an unattended device to exclude
      OSA, followed by 7 days of actigraphy with a sleep log to record sleep duration. Both devices
      will be returned by mail. Subjects with reported total sleep time (TST) between 5 and 10
      hours and absence of moderate to severe OSA will be invited to perform a 2-night nocturnal
      polysomnography (NPSG) (Nights 1-2) and a PiB-PET MR scan (Visit 2).
observational model: Cohort
time perspective: Prospective
measure: Association between Percentage of African Ancestry (%AF) and Slow Wave Sleep (SWS) duration and activity (SWA).
time frame: Determined at baseline.
description: Aim 1 will test if individual % African ancestry (%AF), estimated from 0-100 and computed using a maximum likelihood method for inferring individual admixture based upon allele frequencies ascertained from Utah residents with Northern and Western European ancestry and West African samples, is associated with short SWS duration/ and poor slow wave activity (SWA), determined through polysomnography, in older AAs while controlling for other moderating factors.
measure: Examine association between SWS duration and poor SWA with longitudinal change in amyloid burden.
time frame: Baseline and 2.5 year follow-up
description: Aim 2 will test the effect of race and its interaction with baseline SWS duration and SWA with amyloid plaque burden both at baseline and follow-up by determining mean PiB standard uptake value using PET-MR.
measure: Examine the association between race, SWS duration and poor SWA and cognition using both standardized and sleep-dependent cognitive tests at baseline and follow-up.
time frame: Baseline and 2.5 year follow-up
description: Aim 3 will test the effect of race and baseline SWS duration and poor SWA on overall cognition using standardized and sleep-dependent tests: the UDS 3.0, WHICAP Clinical Core Neuropsychological test battery, as well as a 3-D Virtual Maze Task, both at baseline and follow-up.
arm group label: African Americans
arm group label: Non-Hispanic Whites
intervention type: Procedure
intervention name: PET-MR Scan
description: Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.
arm group label: African Americans
arm group label: Non-Hispanic Whites
intervention type: Drug
intervention name: PiB
description: Subjects will receive a single dose of 555 MBq of PiB and perform a dynamic 30 min PiB PET-MR scan 60 min after injection.
arm group label: African Americans
arm group label: Non-Hispanic Whites
Blood will be drawn for clinical labs and to obtain DNA for ApoE genotyping.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ricardo Osorio, MD
role: Principal Investigator
affiliation: NYU Department of Psychiatry
last name: Payton White
phone: 212-263-7795
email: Payton.white@nyulangone.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: Yes
ipd description: Subjects will have the option to allow their leftover blood and DNA samples to be banked indefinitely for future research related to studies on early diagnosis of Alzheimer's, disease and/or mechanism of neurodegeneration. After the study is completed, the de-identified, archived data will be transmitted to and stored at the CBH Biorepository, under the supervision of Dr. Osorio, for use by other researchers including those outside of the study. Permission to transmit data to the CBH Biorepository will be included in the ICF. During the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens stored for future research. However, withdrawal of consent with regard to biosample storage will not be possible after the study is completed. When the study is completed, access to study data and/or samples will be provided through the CBH Biorepository.
provided document: 