<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/NCT01730430</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00033660</org_study_id>
    <nct_id>NCT01730430</nct_id>
  </id_info>
  <brief_title>Cerebrospinal Fluid (CSF) Biomarkers Alzheimer's Disease (AD) and Non-AD Dementias</brief_title>
  <official_title>Investigation of Biomarkers of Disease State in Alzheimer's Disease and Non-AD Dementias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing&#xD;
      patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects.&#xD;
      The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity&#xD;
      and 60% specificity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll 50 AD subjects, 50 normal controls and approximately 20 subjects with&#xD;
      non-AD dementia. There will be 2 visits (up to 30 days apart), and a telephone follow-up&#xD;
      visit.&#xD;
&#xD;
      This protocol does not include treatment of subjects. Lumbar puncture and phlebotomy are&#xD;
      routine clinical tasks and are associated with a low level of risk. All adverse events will&#xD;
      be documented and reviewed by the PI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ratio of CSF tau to Aβ42 (tau/Aβ42)</measure>
    <time_frame>CSF will be collected at Visit 1 (up to 30 days after the screening visit)</time_frame>
    <description>CSF will be collected in clinic and shipped frozen to Merck's Clinical Development Lab for testing. Any remaining samples will be kept up to 20 years.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Dementias</condition>
  <arm_group>
    <arm_group_label>Collection of CSF</arm_group_label>
    <description>Those with Alzheimer's disease&#xD;
Those with non-Alzheimer's disease dementia&#xD;
Healthy elderly volunteers</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine and cerebral spinal fluid.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Duke Memory Disorders Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each subject must be ≥ 55 to ≤ 85 years of age.&#xD;
&#xD;
          -  Each subject must be able to read at a 6th grade level, as determined by the&#xD;
             investigator, and must have a history of academic achievement and/or employment&#xD;
             sufficient to exclude mental retardation.&#xD;
&#xD;
          -  Each subject must have results of clinical laboratory tests, a physical examination,&#xD;
             vital signs within normal limits or clinically acceptable to the investigator within&#xD;
             28 days prior to enrollment.&#xD;
&#xD;
          -  Each subject (or legal representative) must sign the informed consent form after the&#xD;
             scope and nature of the investigation have been explained to them, and before&#xD;
             screening assessments.&#xD;
&#xD;
        Additional Inclusion Criteria for Normal Controls:&#xD;
&#xD;
          -  Must have a global Clinical Dementia Rating (CDR) score of 0.&#xD;
&#xD;
          -  Must have a Mini-Mental State Examination (MMSE) score ≥ 28.&#xD;
&#xD;
          -  Must have a Z-score ≥ -1.0 in each cognitive domain of memory (including delayed&#xD;
             recall), language, executive function and attention, and visuoconstruction with&#xD;
             neuropsychological tests of choice and adjustment for age, gender, and education level&#xD;
             if indicated.&#xD;
&#xD;
        Additional Inclusion Criteria for AD Subjects:&#xD;
&#xD;
          -  Must meet the criteria for a diagnosis of probable AD based on both&#xD;
&#xD;
               1. the National Institute of Neurological and Communicative Diseases and&#xD;
                  Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)&#xD;
                  criteria, and&#xD;
&#xD;
               2. the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text&#xD;
                  Revision (DSM IV TR) criteria for AD.&#xD;
&#xD;
          -  Must have an MMSE score ≥ 15 and ≤ 26.&#xD;
&#xD;
          -  Must have a clear history of cognitive and functional decline over at least one year&#xD;
             that is either&#xD;
&#xD;
               1. documented in medical records or&#xD;
&#xD;
               2. documented by history from an informant who knows the subject well.&#xD;
&#xD;
          -  Must have an MRI or CT scan that is consistent with a diagnosis of AD within 12 months&#xD;
             prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria for AD Subjects and Normal Controls&#xD;
&#xD;
          -  The subject has a Rosen modified Hachinski Ischemia Score &gt; 4.&#xD;
&#xD;
          -  The subject has a known history of stroke.&#xD;
&#xD;
          -  The subject has evidence of a clinically relevant or unstable neurological or&#xD;
             psychiatric disorder (for AD subjects - other than AD).&#xD;
&#xD;
          -  The subject has a history of alcoholism or drug dependency/abuse within the last 5&#xD;
             years before enrollment.&#xD;
&#xD;
          -  The subject has an ongoing uncontrolled, clinically significant medical condition such&#xD;
             that, in the judgment of the investigator, a subject's participation in the trial&#xD;
             would pose a significant medical risk to the subject.&#xD;
&#xD;
          -  The subject has participated within the last two months in a clinical trial of a novel&#xD;
             therapeutic agent (e.g. bapineuzumab) or has ever been in a clinical trial of an AD&#xD;
             vaccine.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
        Additional Inclusion and Exclusion Criteria for Subject with non-AD dementias&#xD;
&#xD;
          -  Standard clinical diagnostic criteria accepted by the field for non-AD dementias&#xD;
             should be used by the Institution.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Burke, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke UMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Health Center at Morreene Road</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>April 18, 2014</last_update_submitted>
  <last_update_submitted_qc>April 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>non-AD dementias</keyword>
  <keyword>healthy elderly controls</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01730430
org study id: Pro00033660
nct id: NCT01730430
lead sponsor: 
collaborator: 
has dmc: No
To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing
      patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects.
      The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity
      and 60% specificity.
This study will enroll 50 AD subjects, 50 normal controls and approximately 20 subjects with
      non-AD dementia. There will be 2 visits (up to 30 days apart), and a telephone follow-up
      visit.

      This protocol does not include treatment of subjects. Lumbar puncture and phlebotomy are
      routine clinical tasks and are associated with a low level of risk. All adverse events will
      be documented and reviewed by the PI.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Ratio of CSF tau to Aβ42 (tau/Aβ42)
time frame: CSF will be collected at Visit 1 (up to 30 days after the screening visit)
description: CSF will be collected in clinic and shipped frozen to Merck's Clinical Development Lab for testing. Any remaining samples will be kept up to 20 years.
arm group label: Collection of CSF
description: Those with Alzheimer's disease
Those with non-Alzheimer's disease dementia
Healthy elderly volunteers
Blood, urine and cerebral spinal fluid.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James Burke, MD, PhD
role: Principal Investigator
affiliation: Duke UMC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia