<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/NCT03287765</url>
  </required_header>
  <id_info>
    <org_study_id>IND123119,Protocol F</org_study_id>
    <nct_id>NCT03287765</nct_id>
  </id_info>
  <brief_title>Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD (Alzheimer Disease) in Humans</brief_title>
  <acronym>ADRCproj1</acronym>
  <official_title>Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tammie L. S. Benzinger, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate a new radioactive compound used in positron&#xD;
      emission tomography (PET) scans in identifying tau tangles (a certain protein that might be&#xD;
      associated with Alzheimer's disease) in the brain, and if the amount of tau tangles in the&#xD;
      brain has a relationship to cerebrospinal fluid (CSF) biomarkers and cognitive status.&#xD;
&#xD;
      This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of&#xD;
      tau deposition. This radioactive compound is not approved by the United States Food and Drug&#xD;
      Administration (FDA). An MRI will be conducted if one has not been completed completed within&#xD;
      the past 12 months under a related research study. Participants will be asked about their&#xD;
      medical history, family history, surgical history, and current medications. We will evaluate&#xD;
      history of traumatic brain injury (TBI) using the Ohio State University Traumatic Brain&#xD;
      Injury Identification (OSU TBI-ID) Method. This will take approximately 10 minutes.&#xD;
      Participants will be asked to undergo a Mini Mental State Examination (MMSE), which will last&#xD;
      approximately 5-10 minutes.&#xD;
&#xD;
      Additionally, participants may be invited to undergo optional brain PET imaging with&#xD;
      2-deoxy-2-[18F]fluoro-D-glucose fludeoxyglucose (18F-FDG), for measurement of the cerebral&#xD;
      metabolic rate of glucose consumption. At the time of the initial T807-PET study,&#xD;
      participants will be asked if they are willing to undergo repeat T807-PET imaging at least 2&#xD;
      years after the initial study. This follow up study is optional, and participation in the&#xD;
      study and initial T807-PET imaging will not be contingent on agreeing to the 2-year follow up&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">July 19, 2021</completion_date>
  <primary_completion_date type="Actual">May 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Examine the association among T807-PET measures of PHF-tau.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characterize the amount and spatial distribution of T807-PET measures in healthy aging. preclinical AD, and early symptomatic AD.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characterize the amount and spatial distribution of T807-PET measures in preclinical AD.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characterize the amount and spatial distribution of T807-PET measures in early symptomatic AD.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the association among T807-PET measures of concentrations of CSF biomarkers. and cognitive performance.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examine the association among T807-PET measures of cognitive performance.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the change in T807-PET measures over time in asymptomatic amyloid-positive individuals and its association with changes in concentrations of CSF biomarkers.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Experimental 18F-AV-1451</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-AV-1451</intervention_name>
    <description>Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.</description>
    <arm_group_label>Experimental 18F-AV-1451</arm_group_label>
    <other_name>Flortauapir</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Under this study protocol, collaborating physicians and the Knight Alzheimer's Disease&#xD;
        Research Center (ADRC) Clinical Core will refer participants to the Knight ADRC Research&#xD;
        Imaging (KARI) Program for MR and PET imaging to evaluate tau distribution in the brains of&#xD;
        cognitively normal and cognitively impaired individuals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female participants, at least 65 years of age.&#xD;
&#xD;
          2. Participant is willing to undergo a lumbar puncture (LP) or has previously undergone&#xD;
             LP. LP will be conducted under IRB ID 201109100 (PI: Anne Fagan).&#xD;
&#xD;
          3. Participant is able and willing to undergo positron emission tomography (PET) and&#xD;
             magnetic resonance imaging (MRI) of the brain.&#xD;
&#xD;
          4. Pre-menopausal women must have a negative urine pregnancy test within 24 hours&#xD;
             preceding T807 drug administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has any condition that, in the Investigator's opinion, could increase risk to the&#xD;
             participant, limit the participant's ability to tolerate the experimental procedures,&#xD;
             or interfere with the collection/analysis of the data (for example, participants with&#xD;
             severe chronic back pain might not be able to lie still during the scanning&#xD;
             procedures).&#xD;
&#xD;
          2. Is deemed likely unable to perform the imaging procedures for any reason.&#xD;
&#xD;
          3. Has a history of Torsades de Pointes or is taking medications known to prolong or may&#xD;
             prolong QT interval (refer to study's list of restricted medications).&#xD;
&#xD;
          4. Has known hypersensitivity to T807 or any of its excipients.&#xD;
&#xD;
          5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to&#xD;
             lie still for long periods) that make it unsafe for the individual to participate.&#xD;
&#xD;
          6. Severe claustrophobia.&#xD;
&#xD;
          7. Currently pregnant or breast-feeding. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tammie Benzinger, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 31, 2016</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Tammie L. S. Benzinger, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Radiology &amp; Neurological Surgery</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Tauopathies</keyword>
  <keyword>cognitive impairment</keyword>
  <keyword>CNS Diseases</keyword>
  <keyword>neurodegenerative disease</keyword>
  <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>The Investigators may share the participant's data with other researchers that may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. The Investigators may also share the research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers will be able to look at the information.</ipd_description>
  </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/NCT03287765
org study id: IND123119,Protocol F
nct id: NCT03287765
lead sponsor: 
has dmc: No
The purpose of this research study is to evaluate a new radioactive compound used in positron
      emission tomography (PET) scans in identifying tau tangles (a certain protein that might be
      associated with Alzheimer's disease) in the brain, and if the amount of tau tangles in the
      brain has a relationship to cerebrospinal fluid (CSF) biomarkers and cognitive status.

      This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of
      tau deposition. This radioactive compound is not approved by the United States Food and Drug
      Administration (FDA). An MRI will be conducted if one has not been completed completed within
      the past 12 months under a related research study. Participants will be asked about their
      medical history, family history, surgical history, and current medications. We will evaluate
      history of traumatic brain injury (TBI) using the Ohio State University Traumatic Brain
      Injury Identification (OSU TBI-ID) Method. This will take approximately 10 minutes.
      Participants will be asked to undergo a Mini Mental State Examination (MMSE), which will last
      approximately 5-10 minutes.

      Additionally, participants may be invited to undergo optional brain PET imaging with
      2-deoxy-2-[18F]fluoro-D-glucose fludeoxyglucose (18F-FDG), for measurement of the cerebral
      metabolic rate of glucose consumption. At the time of the initial T807-PET study,
      participants will be asked if they are willing to undergo repeat T807-PET imaging at least 2
      years after the initial study. This follow up study is optional, and participation in the
      study and initial T807-PET imaging will not be contingent on agreeing to the 2-year follow up
      study.
observational model: Other
time perspective: Prospective
measure: Examine the association among T807-PET measures of PHF-tau.
time frame: 5 years
measure: Characterize the amount and spatial distribution of T807-PET measures in healthy aging. preclinical AD, and early symptomatic AD.
time frame: 5 years
measure: Characterize the amount and spatial distribution of T807-PET measures in preclinical AD.
time frame: 5 years
measure: Characterize the amount and spatial distribution of T807-PET measures in early symptomatic AD.
time frame: 5 years
measure: Examine the association among T807-PET measures of concentrations of CSF biomarkers. and cognitive performance.
time frame: 5 years
measure: Examine the association among T807-PET measures of cognitive performance.
time frame: 5 years
measure: Evaluate the change in T807-PET measures over time in asymptomatic amyloid-positive individuals and its association with changes in concentrations of CSF biomarkers.
time frame: 5 years
arm group label: Experimental 18F-AV-1451
intervention type: Drug
intervention name: 18F-AV-1451
description: Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
arm group label: Experimental 18F-AV-1451
other name: Flortauapir
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Tammie Benzinger, MD, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Tammie L. S. Benzinger, MD, PhD
investigator title: Professor of Radiology & Neurological Surgery
mesh term: Alzheimer Disease
sharing ipd: Yes
ipd description: The Investigators may share the participant's data with other researchers that may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. The Investigators may also share the research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers will be able to look at the information.