<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/NCT01723488</url>
  </required_header>
  <id_info>
    <org_study_id>T808000</org_study_id>
    <nct_id>NCT01723488</nct_id>
  </id_info>
  <brief_title>A Phase 0, Open Label, Multi-Center, Exploratory and Safety Study of [F-18]T808</brief_title>
  <acronym>T808</acronym>
  <official_title>A Phase 0, Open Label, Non-Randomized, Multi-Center, Exploratory and Safety Study of [F-18]T808</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      [F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the&#xD;
      human brain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T808 might be useful as a&#xD;
      non-invasive assessment tool in the clinical evaluation of subjects with conditions&#xD;
      associated with tau protein aggregates, such as Alzheimer's disease. The information&#xD;
      collected under this exploratory study will not be used for diagnostic purposes, assessments&#xD;
      of the participant's response to therapy or for clinical management of the participants.&#xD;
      However, this exploratory study will provide baseline information on the safety,&#xD;
      biodistribution, and dosimetry of [F-18]T808. These data will aid in the design of future&#xD;
      studies of [F-18]T808 in patients with Alzheimer's disease. Overall, this study will provide&#xD;
      initial data that inform the development of [F-18]T808 as the first PET imaging agent for&#xD;
      human tau protein related pathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated in anticipation of transfer of ownership to Avid Radiopharmaceuticals.&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To monitor and assess the safety of IV administration of [F-18]T808</measure>
    <time_frame>up to15 days per patient.</time_frame>
    <description>To monitor and assess the safety of IV administration of [F-18]T808 To evaluate the bio-distribution and radiation dosimetry of [F-18]T808 in participants with low probability of Alzheimer&quot;s disease (AD) using PET/CT whole body imaging To evaluate the metabolism of [F-18]T808 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration To evaluate [F-18]T808 uptake and signal/background information in brain PET/CT imaging of participants with a high probability of currently being positive for AD and age-matched participants with a low probability of currently being positive for AD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To begin collection of baseline [F-18]T808 PET/CT imaging data</measure>
    <time_frame>up to14 days per patient</time_frame>
    <description>To begin collection of baseline [F-18]T808 PET/CT imaging data To gain information to improve the study design for the conduct of future trials</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Alzheimers Disease</condition>
  <arm_group>
    <arm_group_label>Tau diagnostic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: Tau diagnostic [F18] T808</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>[F18] T808</intervention_name>
    <description>Dose for normal volunteer undergoing dosimetry evaluation will not exceed 20 mCi, dose for high probability of Alzheimer's and low probability Alzheimer's undergoing brain imaging only will not exceed 10 mCi</description>
    <arm_group_label>Tau diagnostic</arm_group_label>
    <other_name>Tau [F-18]T808</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Low Probability for AD Participants (Group 1)&#xD;
&#xD;
          -  Participant is of any race/gender/ethnicity who has reached his or her 55th birthday&#xD;
             at the time of informed consent.&#xD;
&#xD;
          -  Participant provides written informed consent Participant is capable of complying with&#xD;
             study procedures&#xD;
&#xD;
          -  Participant is capable of communicating with study personnel&#xD;
&#xD;
          -  Participant understands and speaks English&#xD;
&#xD;
          -  Participant has at least an 8th Grade education&#xD;
&#xD;
          -  In the Investigator&quot;s opinion, participant has a low probability of being currently&#xD;
             positive for AD as determined by a Mini Mental State Examination (MMSE ≥ 28) defined&#xD;
             in APPENDIX VI of XXX protocol&#xD;
&#xD;
          -  Participant has no significant hepatic or renal disease as defined by previous medical&#xD;
             history and lab results are within the following ranges: Total bilirubin within 2x&#xD;
             institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of&#xD;
             normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x&#xD;
             institutional upper limits of normal BUN within 2x institutional upper limits of&#xD;
             normal&#xD;
&#xD;
        High Probability for AD Participants (Group 2)&#xD;
&#xD;
          -  Participant is of any race/gender/ethnicity who has reached his or her 55th birthday&#xD;
             at the time of informed consent.&#xD;
&#xD;
          -  Participant or participant&quot;s legally acceptable representative provides written&#xD;
             informed consent Participant is capable of complying with study procedures&#xD;
&#xD;
          -  Participant is capable of communicating with study personnel&#xD;
&#xD;
          -  Participant understands and speaks English&#xD;
&#xD;
          -  Participant has at least an 8th Grade education In the Investigator&quot;s opinion,&#xD;
             *participant has a high probability of being currently positive for AD that is&#xD;
             determined by a Mini Mental State Examination (MMSE &lt; 17) defined in APPENDIX VI of&#xD;
             XXX protocol&#xD;
&#xD;
          -  Participant has no significant hepatic or renal disease as defined by previous medical&#xD;
             history, and lab results are within the following ranges: Total bilirubin within 2x&#xD;
             institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of&#xD;
             normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x&#xD;
             institutional upper limits of normal BUN within 2x institutional upper limits of&#xD;
             normal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Officer</last_name>
    <role>Study Director</role>
    <affiliation>Avid Radiopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>July 18, 2013</last_update_submitted>
  <last_update_submitted_qc>July 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AD</keyword>
  <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/NCT01723488
org study id: T808000
nct id: NCT01723488
lead sponsor: 
has dmc: No
[F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the
      human brain.
Siemens Molecular Imaging (SMI) is seeking to determine if [F-18]T808 might be useful as a
      non-invasive assessment tool in the clinical evaluation of subjects with conditions
      associated with tau protein aggregates, such as Alzheimer's disease. The information
      collected under this exploratory study will not be used for diagnostic purposes, assessments
      of the participant's response to therapy or for clinical management of the participants.
      However, this exploratory study will provide baseline information on the safety,
      biodistribution, and dosimetry of [F-18]T808. These data will aid in the design of future
      studies of [F-18]T808 in patients with Alzheimer's disease. Overall, this study will provide
      initial data that inform the development of [F-18]T808 as the first PET imaging agent for
      human tau protein related pathology.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: To monitor and assess the safety of IV administration of [F-18]T808
time frame: up to15 days per patient.
description: To monitor and assess the safety of IV administration of [F-18]T808 To evaluate the bio-distribution and radiation dosimetry of [F-18]T808 in participants with low probability of Alzheimer"s disease (AD) using PET/CT whole body imaging To evaluate the metabolism of [F-18]T808 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration To evaluate [F-18]T808 uptake and signal/background information in brain PET/CT imaging of participants with a high probability of currently being positive for AD and age-matched participants with a low probability of currently being positive for AD
measure: To begin collection of baseline [F-18]T808 PET/CT imaging data
time frame: up to14 days per patient
description: To begin collection of baseline [F-18]T808 PET/CT imaging data To gain information to improve the study design for the conduct of future trials
arm group label: Tau diagnostic
arm group type: Experimental
description: Experimental: Tau diagnostic [F18] T808
intervention type: Radiation
intervention name: [F18] T808
description: Dose for normal volunteer undergoing dosimetry evaluation will not exceed 20 mCi, dose for high probability of Alzheimer's and low probability Alzheimer's undergoing brain imaging only will not exceed 10 mCi
arm group label: Tau diagnostic
other name: Tau [F-18]T808
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chief Medical Officer
role: Study Director
affiliation: Avid Radiopharmaceuticals
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease