<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/NCT03040713</url>
  </required_header>
  <id_info>
    <org_study_id>18F-AV-1451-A19</org_study_id>
    <nct_id>NCT03040713</nct_id>
  </id_info>
  <brief_title>Flortaucipir PET Imaging in Subjects With FTD</brief_title>
  <official_title>18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avid Radiopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Avid Radiopharmaceuticals</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>
      This study is designed to assess the usefulness of flortaucipir in Positron Emission&#xD;
      Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Actual">October 24, 2018</completion_date>
  <primary_completion_date type="Actual">October 24, 2018</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>Qualitative Evaluation of Flortaucipir PET Scans</measure>
    <time_frame>baseline scan</time_frame>
    <description>Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative Evaluation of Flortaucipir PET Scans</measure>
    <time_frame>baseline scan</time_frame>
    <description>Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Frontotemporal Dementia</condition>
  <arm_group>
    <arm_group_label>FTD Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flortaucipir F18</intervention_name>
    <description>370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose</description>
    <arm_group_label>FTD Subjects</arm_group_label>
    <other_name>18F-AV-1451</other_name>
    <other_name>[F-18]T807</other_name>
    <other_name>LY3191748</other_name>
    <other_name>Tauvid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Brain PET scan</intervention_name>
    <description>positron emission tomography (PET) scan of the brain</description>
    <arm_group_label>FTD Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with&#xD;
             expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes&#xD;
             associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron&#xD;
             disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia,&#xD;
             progressive supranuclear palsy syndrome and corticobasal syndrome.&#xD;
&#xD;
          -  Have provided informed consent or have a legally authorized (LAR) provide consent for&#xD;
             study procedures&#xD;
&#xD;
          -  Have had volumetric brain MRI obtained in site's companion protocol within one year of&#xD;
             enrollment&#xD;
&#xD;
          -  Can tolerate PET scan procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or&#xD;
             endocrine disturbances that pose potential safety risk&#xD;
&#xD;
          -  Have history of risk factors for Torsades de Pointes (TdP) or taking medication known&#xD;
             to cause QT prolongation&#xD;
&#xD;
          -  Have history of drug or alcohol dependence within the last year&#xD;
&#xD;
          -  Are females of childbearing potential who are not surgically sterile, not refraining&#xD;
             from sexual activity, or not using reliable contraception&#xD;
&#xD;
          -  Have history of relevant severe drug allergy or hypersensitivity&#xD;
&#xD;
          -  Have received an investigational medication under FDA IND protocol within 30 days of&#xD;
             planned imaging session&#xD;
&#xD;
          -  Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging&#xD;
             session&#xD;
&#xD;
          -  Possess PET scan evidence of amyloid deposition&#xD;
&#xD;
          -  Determined by the investigator to be unsuitable for this type of study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Officer</last_name>
    <role>Study Chair</role>
    <affiliation>Avid Radiopharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Movement Disorder Center, UCSD</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory and Aging Center, UCSF</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>July 24, 2020</results_first_submitted>
  <results_first_submitted_qc>September 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2020</results_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</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>Dementia</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03040713/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03040713/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment occurred between Apr 2017 and Oct 2018.</recruitment_details>
      <pre_assignment_details>As a result of a positive amyloid scan at screening, 1 subject was discontinued prior to administration of flortaucipir. Two additional subjects had positive amyloid scans and received flortaucipir, but were excluded from the per protocol population results (n=13).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FTD Subjects</title>
          <description>Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Positive amyloid scan</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All subjects receiving one dose of flortaucipir in the study</population>
      <group_list>
        <group group_id="B1">
          <title>FTD Subjects</title>
          <description>Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or TDP-43 pathology receiving a flortaucipir PET scan</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.7" spread="6.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MMSE</title>
          <description>Mini-mental status exam (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.6" spread="6.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Qualitative Evaluation of Flortaucipir PET Scans</title>
        <description>Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.</description>
        <time_frame>baseline scan</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FTD Subjects</title>
            <description>Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or TDP-43 pathology receiving a flortaucipir PET scan</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Evaluation of Flortaucipir PET Scans</title>
          <description>Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Advanced AD Scan Pattern (τAD++)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate AD Scan Pattern (τAD+)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not AD Scan Pattern (τAD-)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quantitative Evaluation of Flortaucipir PET Scans</title>
        <description>Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.</description>
        <time_frame>baseline scan</time_frame>
        <population>All amyloid negative FTD subjects who had a PET scan that was able to be quantitatively evaluated (n=12). One subject did not have magnetic resonance imaging available, so quantitation was not possible.</population>
        <group_list>
          <group group_id="O1">
            <title>FTD Subjects</title>
            <description>Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or TDP-43 pathology receiving a flortaucipir PET scan</description>
          </group>
        </group_list>
        <measure>
          <title>Quantitative Evaluation of Flortaucipir PET Scans</title>
          <description>Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.</description>
          <population>All amyloid negative FTD subjects who had a PET scan that was able to be quantitatively evaluated (n=12). One subject did not have magnetic resonance imaging available, so quantitation was not possible.</population>
          <units>standardized uptake value ratio (SUVr)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MUBADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00903" spread="0.036582"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parietal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91992" spread="0.054753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94920" spread="0.041189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frontal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89825" spread="0.086118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63508" spread="0.130466"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected at scan visit and for 48 hours after flortaucipir administration.</time_frame>
      <desc>Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>FTD Subjects Safety Population</title>
          <description>Subjects diagnosed with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or TDP-43 pathology receiving a flortaucipir PET scan</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Avid Radiopharmaceuticals, Inc.</organization>
      <phone>215-298-0700</phone>
      <email>clinicaloperations@avidrp.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03040713
org study id: 18F-AV-1451-A19
nct id: NCT03040713
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to assess the usefulness of flortaucipir in Positron Emission
      Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Qualitative Evaluation of Flortaucipir PET Scans
time frame: baseline scan
description: Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
measure: Quantitative Evaluation of Flortaucipir PET Scans
time frame: baseline scan
description: Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
arm group label: FTD Subjects
arm group type: Experimental
description: Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan
intervention type: Drug
intervention name: Flortaucipir F18
description: 370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose
arm group label: FTD Subjects
other name: 18F-AV-1451
other name: [F-18]T807
other name: LY3191748
other name: Tauvid
intervention type: Procedure
intervention name: Brain PET scan
description: positron emission tomography (PET) scan of the brain
arm group label: FTD Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chief Medical Officer
role: Study Chair
affiliation: Avid Radiopharmaceuticals, Inc.
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dementia
mesh term: Frontotemporal Dementia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 