<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/NCT03283449</url>
  </required_header>
  <id_info>
    <org_study_id>STU00200893</org_study_id>
    <secondary_id>R01AG056258</secondary_id>
    <nct_id>NCT03283449</nct_id>
  </id_info>
  <brief_title>Tau PET Imaging in Atypical Dementias</brief_title>
  <official_title>Tau PET Imaging in Atypical Dementias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <brief_summary>
    <textblock>
      The goal of this study is to demonstrate the feasibility of mapping tau pathology in subjects&#xD;
      with Primary Progressive Aphasia, using PET protocol with F-AV-1451 (trade name AV-1451) and&#xD;
      to systematically document the extent and location of tau pathology in PPA patients in vivo&#xD;
      using the same techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tau levels in PPA participants</measure>
    <time_frame>2 years</time_frame>
    <description>Tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) in cortical and medial temporal regions.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Primary Progressive Aphasia With Suspected Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>AV-1451 Recipients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm of the study will all receive an injection of 10 Mci of AV-1451 and then be scanned in a PET scanner for brain imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-AV-1451</intervention_name>
    <arm_group_label>AV-1451 Recipients</arm_group_label>
    <other_name>AV-1451</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET</intervention_name>
    <description>PET scanner for brain imaging</description>
    <arm_group_label>AV-1451 Recipients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have primary progressive aphasia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Receiving radiation clinically&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily Rogalski, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Seyi Adeolu</last_name>
    <phone>312-503-2398</phone>
    <email>PPA.Research@northwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emily Rogalski, Ph.D.</last_name>
    <phone>312-503-1155</phone>
    <email>erogalski@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cognitive Neurology and Alzheimer's Disease Center - Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seyi Adeolu</last_name>
      <phone>312-503-2398</phone>
      <email>PPA.Research@northwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>Emily Rogalski, Ph.D.</last_name>
      <phone>312-503-1155</phone>
      <email>erogalski@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Emily Rogalski, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.brain.northwestern.edu/join/index.html</url>
    <description>PPA Research at Northwestern University</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 16, 2016</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Emily Rogalski</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Aphasia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Frontotemporal 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/NCT03283449
org study id: STU00200893
secondary id: R01AG056258
nct id: NCT03283449
lead sponsor: 
collaborator: 
The goal of this study is to demonstrate the feasibility of mapping tau pathology in subjects
      with Primary Progressive Aphasia, using PET protocol with F-AV-1451 (trade name AV-1451) and
      to systematically document the extent and location of tau pathology in PPA patients in vivo
      using the same techniques.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tau levels in PPA participants
time frame: 2 years
description: Tau deposition as measured by 18F-AV-1451 standardized uptake value ratio (SUVR) in cortical and medial temporal regions.
arm group label: AV-1451 Recipients
arm group type: Experimental
description: Participants in this arm of the study will all receive an injection of 10 Mci of AV-1451 and then be scanned in a PET scanner for brain imaging.
intervention type: Drug
intervention name: 18F-AV-1451
arm group label: AV-1451 Recipients
other name: AV-1451
intervention type: Device
intervention name: PET
description: PET scanner for brain imaging
arm group label: AV-1451 Recipients
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
last name: Emily Rogalski, Ph.D.
role: Principal Investigator
affiliation: Northwestern University
last name: Seyi Adeolu
phone: 312-503-2398
email: PPA.Research@northwestern.edu
last name: Emily Rogalski, Ph.D.
phone: 312-503-1155
email: erogalski@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://www.brain.northwestern.edu/join/index.html
description: PPA Research at Northwestern University
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Emily Rogalski
investigator title: Associate Professor
mesh term: Alzheimer Disease
mesh term: Aphasia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Frontotemporal Dementia