<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/NCT01733355</url>
  </required_header>
  <id_info>
    <org_study_id>T807000</org_study_id>
    <nct_id>NCT01733355</nct_id>
  </id_info>
  <brief_title>A Phase 0, Open Label, Multi-center Exploratory and Safety Study of [F-18]T807</brief_title>
  <official_title>A Phase 0, Open Label, Non-randomized, Multi-center Exploratory and Safety Study of [F-18]T807</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]T807 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]T807 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]T807. These data will aid in the design of future&#xD;
      studies of [F-18]T807 in patients with Alzheimer's disease. Overall, this study will provide&#xD;
      initial data that inform the development of [F-18]T807 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 evaluate the bio-distribution and radiation dosimetry of [F-18]T807 in participants with low probability of Alzheimer's disease (AD) using PET/CT whole body imaging</measure>
    <time_frame>up to 15 days per patient</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the metabolism of [F-18]T807 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration</measure>
    <time_frame>up to 15 days per patient</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate [F-18]T807 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>
    <time_frame>upto 15 days per patient</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the safety of IV administration of [F-18]T807</measure>
    <time_frame>up to 24 hours post [F18]T807 administration</time_frame>
    <description>Safety will be monitored for all subjects by the:&#xD;
Number of subjects experiencing adverse events from baseline to 24 hours post-administration.&#xD;
Number and type of adverse events.&#xD;
Changes in clinical laboratory assessments (CBC and clinical chemistry)from baseline to 24 hours post administration.&#xD;
Changes in physical examination from baseline to 24 hours post administration.&#xD;
Changes in vital sign measurements (systolic blood pressure [mmHg]; diastolic blood pressure [mmHg], pulse rate [bpm] and body temperature) from baseline prior to [F-18]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration)and at 24 hours post administration.&#xD;
Changes in ECG measurements, from baseline prior to [F-18]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration) and at 24 hours post administration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To begin collection of baseline [F-18]T807 PET/CT imaging data</measure>
    <time_frame>up to 15 days per patient</time_frame>
    <description>The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of [F-18]T807</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To gain information to improve the study design for the conduct of future trials</measure>
    <time_frame>up to 15 days per patient</time_frame>
    <description>The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of [F-18]T807</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Alzheimers Disease</condition>
  <condition>AD</condition>
  <arm_group>
    <arm_group_label>Tau diagnostic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[F18] T807</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>[F18] T807</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]T807</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria; Low Probability for AD Participants (Group 1)&#xD;
&#xD;
          -  Participant has reached his or her 55th birthday at the time of informed consent&#xD;
             (Participant is male or female of any race / ethnicity)&#xD;
&#xD;
          -  Participant provides written informed consent&#xD;
&#xD;
          -  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&#xD;
&#xD;
          -  In the Investigator'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 protocol T807000, IND 114102&#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:&#xD;
&#xD;
          -  Total bilirubin within 2x institutional upper limits of normal&#xD;
&#xD;
          -  AST (SGOT) ≤ 2.5 x institutional upper limits of normal&#xD;
&#xD;
          -  ALT (SGPT) ≤ 2.5 x institutional upper limits of normal&#xD;
&#xD;
          -  Creatinine ≤ 2x institutional upper limits of normal&#xD;
&#xD;
          -  BUN within 2x institutional upper limits of normal&#xD;
&#xD;
        High Probability for AD Participants (Group 2)&#xD;
&#xD;
          -  Participant has reached his or her 55th birthday at the time of informed consent&#xD;
             (Participant is male or female of any race / ethnicity)&#xD;
&#xD;
          -  Participant or participant's legally acceptable representative provides written&#xD;
             informed consent&#xD;
&#xD;
          -  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&#xD;
&#xD;
          -  In the Investigator's opinion, participant has a high probability of being currently&#xD;
             positive for AD that is determined by a Mini Mental State Examination (MMSE &lt; 17)&#xD;
             defined in APPENDIX VI of protocol T807000, IND 114102.&#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:&#xD;
&#xD;
          -  Total bilirubin within 2x institutional upper limits of normal&#xD;
&#xD;
          -  AST (SGOT) ≤ 2.5 x institutional upper limits of normal&#xD;
&#xD;
          -  ALT (SGPT) ≤ 2.5 x institutional upper limits of normal&#xD;
&#xD;
          -  Creatinine ≤ 2x institutional upper limits of normal&#xD;
&#xD;
          -  BUN within 2x institutional upper limits of normal&#xD;
&#xD;
        Exclusion Criteria; All Participants&#xD;
&#xD;
          -  Female participant is pregnant or nursing&#xD;
&#xD;
          -  Participant has prior history of stroke or other condition of the head or neck that,&#xD;
             in the Investigator's opinion, might affect circulation to the head or image&#xD;
             interpretation&#xD;
&#xD;
          -  Participant has other neurodegenerative disease that is associated with cognitive&#xD;
             impairment or dementia&#xD;
&#xD;
          -  Participant has a medical condition that might be associated with elevated amyloid&#xD;
             levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis,&#xD;
             Down's syndrome&#xD;
&#xD;
          -  Participant has a history of significant cerebrovascular disease&#xD;
&#xD;
          -  Participant has previously received [F-18]T807 at any time&#xD;
&#xD;
          -  Participant has been involved in an investigative, radioactive research procedure&#xD;
             within the past 14 days&#xD;
&#xD;
          -  Participant has any other condition or personal circumstance that, in the judgment of&#xD;
             the Investigator, might interfere with the collection of complete data or data quality&#xD;
&#xD;
          -  Participant has a history in the last five years of significant prescription or&#xD;
             non-prescription drug or alcohol abuse, including but not limited to marijuana,&#xD;
             cocaine, heroin or derivatives&#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>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 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>
  <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/NCT01733355
org study id: T807000
nct id: NCT01733355
lead sponsor: 
has dmc: No
[F-18]T807 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]T807 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]T807. These data will aid in the design of future
      studies of [F-18]T807 in patients with Alzheimer's disease. Overall, this study will provide
      initial data that inform the development of [F-18]T807 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 evaluate the bio-distribution and radiation dosimetry of [F-18]T807 in participants with low probability of Alzheimer's disease (AD) using PET/CT whole body imaging
time frame: up to 15 days per patient
measure: To evaluate the metabolism of [F-18]T807 in participants with low probability of AD using serial blood samples collected pre- and post-IP administration
time frame: up to 15 days per patient
measure: To evaluate [F-18]T807 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
time frame: upto 15 days per patient
measure: To assess the safety of IV administration of [F-18]T807
time frame: up to 24 hours post [F18]T807 administration
description: Safety will be monitored for all subjects by the:
Number of subjects experiencing adverse events from baseline to 24 hours post-administration.
Number and type of adverse events.
Changes in clinical laboratory assessments (CBC and clinical chemistry)from baseline to 24 hours post administration.
Changes in physical examination from baseline to 24 hours post administration.
Changes in vital sign measurements (systolic blood pressure [mmHg]; diastolic blood pressure [mmHg], pulse rate [bpm] and body temperature) from baseline prior to [F-18]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration)and at 24 hours post administration.
Changes in ECG measurements, from baseline prior to [F-18]T807 administration, at 60 +/- 15 minutes post administration, at the end of the final imaging session (approximately 100 minutes post administration) and at 24 hours post administration.
measure: To begin collection of baseline [F-18]T807 PET/CT imaging data
time frame: up to 15 days per patient
description: The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of [F-18]T807
measure: To gain information to improve the study design for the conduct of future trials
time frame: up to 15 days per patient
description: The secondary endpoint of this investigational study is the collection of baseline whole body PET/CT images and PET/CT images of the brain, following administration of [F-18]T807
arm group label: Tau diagnostic
arm group type: Experimental
description: [F18] T807
intervention type: Radiation
intervention name: [F18] T807
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]T807
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