<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/NCT03809351</url>
  </required_header>
  <id_info>
    <org_study_id>R19-006</org_study_id>
    <nct_id>NCT03809351</nct_id>
  </id_info>
  <brief_title>UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy</brief_title>
  <acronym>AV1451 ADC</acronym>
  <official_title>UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary objective of this study is to measure the concentration and the regional brain&#xD;
      distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the&#xD;
      UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to&#xD;
      demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing&#xD;
      UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau&#xD;
      levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this&#xD;
      imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled&#xD;
      in an ongoing [C-11]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and&#xD;
      cognitive statuses will be compared in terms of race and vascular risk factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">July 8, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 8, 2025</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>Measurement of pathological tau deposition in the brain.</measure>
    <time_frame>5 years</time_frame>
    <description>The amount and regional distribution of pathological tau in the brains of study participants will be measured with [F-18]AV-1451-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>[F-18]AV-1451-PET/MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in this study will undergo a tau-PET imaging using the tracer [F-18]AV-1451 with a simultaneous PET/MRI system. The [F-18]AV-1451 dosage is 740MBq (10 mCi) given intravenously, and the PET/MRI imaging will occur 75-105 min after tracer injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[F-18]AV-1451-PET</intervention_name>
    <description>All study participants will undergo brain imaging with [F-18]AV-1451-PET/MRI. [F-18]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.</description>
    <arm_group_label>[F-18]AV-1451-PET/MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.&#xD;
&#xD;
          2. Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research&#xD;
             protocol. The amyloid-PET study does not have to have been completed prior to&#xD;
             enrollment and participation in this tau-PET study.&#xD;
&#xD;
          3. Negative urine or serum hCG test within 2 days of [F-18]AV-1451 administration in&#xD;
             women of child bearing potential. Women who are post-menopausal with at least 1 year&#xD;
             since last menses or documented surgical sterilization will not require pregnancy&#xD;
             testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Meets any exclusion criteria for the UAB-ADC study.&#xD;
&#xD;
          2. Inability or contraindication for undergoing MRI and/or PET imaging&#xD;
&#xD;
          3. Inability to participate in the imaging studies due to severity of dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chinara Dosse</last_name>
    <phone>(205) 934-4501</phone>
    <email>cdosse@uabmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carol Chambless</last_name>
    <phone>(205) 975-9569</phone>
    <email>cchambless@uabmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UAB</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>April Riddle</last_name>
      <phone>205-934-6504</phone>
      <email>ariddle@uabmc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Jonathan E McConathy</investigator_full_name>
    <investigator_title>Director, Division of Molecular Imaging and Therapeutics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT03809351
org study id: R19-006
nct id: NCT03809351
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to measure the concentration and the regional brain
      distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the
      UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to
      demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing
      UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau
      levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this
      imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled
      in an ongoing [C-11]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and
      cognitive statuses will be compared in terms of race and vascular risk factors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measurement of pathological tau deposition in the brain.
time frame: 5 years
description: The amount and regional distribution of pathological tau in the brains of study participants will be measured with [F-18]AV-1451-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.
arm group label: [F-18]AV-1451-PET/MRI
arm group type: Experimental
description: All participants in this study will undergo a tau-PET imaging using the tracer [F-18]AV-1451 with a simultaneous PET/MRI system. The [F-18]AV-1451 dosage is 740MBq (10 mCi) given intravenously, and the PET/MRI imaging will occur 75-105 min after tracer injection.
intervention type: Drug
intervention name: [F-18]AV-1451-PET
description: All study participants will undergo brain imaging with [F-18]AV-1451-PET/MRI. [F-18]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.
arm group label: [F-18]AV-1451-PET/MRI
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chinara Dosse
phone: (205) 934-4501
email: cdosse@uabmc.edu
last name: Carol Chambless
phone: (205) 975-9569
email: cchambless@uabmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Jonathan E McConathy
investigator title: Director, Division of Molecular Imaging and Therapeutics
mesh term: Alzheimer Disease