<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/NCT04507139</url>
  </required_header>
  <id_info>
    <org_study_id>PPMI-004</org_study_id>
    <nct_id>NCT04507139</nct_id>
  </id_info>
  <brief_title>Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™</brief_title>
  <official_title>Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™ (PPMI Early Imaging)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael J. Fox Foundation for Parkinson's Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Michael J. Fox Foundation for Parkinson's Research</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Directly examine whether early (6-month) imaging with DaTscan and [¹⁸F] AV-133 will provide&#xD;
      an early signal of disease progression in recently diagnosed untreated PD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a longitudinal, multi-center study to assess progression of DaTscan and [18F]&#xD;
      AV-133 imaging in PD and Prodromal patients. Participants will be followed for up to 24&#xD;
      months. Approximately 50 early PD participants and 100 Prodromal participants will be&#xD;
      recruited from up to 15 sites. Participants will be comprehensively assessed at baseline and&#xD;
      follow up according to the Schedule of Activities for the respective cohort. Participants&#xD;
      will undergo imaging assessments with DaTscan and [18F] AV-133 and clinical (motor,&#xD;
      neuropsychiatric and cognitive) assessments. Data will be collected by each site under&#xD;
      uniformly established protocols and data will be stored and analyzed at designated core&#xD;
      facilities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Rate of Change</measure>
    <time_frame>24 months</time_frame>
    <description>The mean rates of change and the variability around the mean of imaging outcomes in early and Prodromal PD patients, and where appropriate the comparison of these rates between PD patient subsets at study intervals ranging from 6 months to 24 months. Specific examples of outcomes include dopamine transporter striatal uptake and vesicular monoamine transporter type-2 uptake. PD patient subsets may be defined by baseline assessments, genetic mutation, progression milestones and/or rate of clinical, imaging, or biomic change.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Parkinson Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 50 early PD and 100 prodromal participants will be recruited from up to 15&#xD;
        sites internationally.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A PD participant consented to PPMI Clinical, or, a Prodromal participant confirmed&#xD;
             eligible to proceed to PPMI Clinical Baseline visit.&#xD;
&#xD;
          2. Able to provide informed consent.&#xD;
&#xD;
          3. Women may not be pregnant, lactating or planning pregnancy during the study.&#xD;
&#xD;
               -  Includes a negative serum pregnancy test prior to Baseline 18F-AV-133 injection.&#xD;
&#xD;
               -  Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day&#xD;
                  of Baseline PET scan.&#xD;
&#xD;
               -  Women participating in the study must be of non-childbearing potential or be&#xD;
                  using a highly effective method of birth control 14 days prior to until at least&#xD;
                  24 hours after the last injection of 18F-AV-133.&#xD;
&#xD;
                    -  Non-childbearing potential is defined as a female that must be either&#xD;
                       postmenopausal (no menses for at least 12 months prior to Screening) or&#xD;
                       surgically sterile (bilateral tubal ligation, bilateral oophorectomy or&#xD;
                       hysterectomy).&#xD;
&#xD;
                    -  Highly effective method of birth control is defined as practicing at least&#xD;
                       one of the following: A birth control method that results in a less than 1%&#xD;
                       per year failure rate when used consistently and correctly, such as oral&#xD;
                       contraceptives for at least 3 months prior to injection, an intrauterine&#xD;
                       device (IUD) for at least 2 months prior to injection, or barrier methods,&#xD;
                       e.g., diaphragm or combination condom and spermicide. Periodic abstinence&#xD;
                       (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not&#xD;
                       acceptable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received any of the following medications that might interfere with 18F- AV-133 PET&#xD;
             imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative,&#xD;
             within 1 month prior to the Baseline 18F-AV-133 injection.&#xD;
&#xD;
          2. Have current clinically significant cardiovascular disease or abnormalities on&#xD;
             screening ECG (including but not limited to QTc &gt; 450 msec).&#xD;
&#xD;
          3. Are currently taking medications that are known to cause QT- prolongation&#xD;
&#xD;
          4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of&#xD;
             the investigator might preclude participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute For Neurodegenerative Disorders</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheryl Winakor</last_name>
      <phone>203-401-4398</phone>
      <email>cwinakor@invicro.com</email>
    </contact>
    <investigator>
      <last_name>David Russell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Boston University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raymond James</last_name>
      <phone>617-638-7745</phone>
      <email>rcjames@bu.edu</email>
    </contact>
    <investigator>
      <last_name>Marie Saint-Hilaire</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashwini Ramachandran</last_name>
      <phone>215-829-6952</phone>
      <email>ashwini.ramachandran@pennmedicine.upenn.edu</email>
    </contact>
    <investigator>
      <last_name>Nabila Dahodwala</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute for Neurodegenerative Disorders</investigator_affiliation>
    <investigator_full_name>Ken Marek, MD</investigator_full_name>
    <investigator_title>Protocol Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Parkinson</keyword>
  <keyword>Bio-markers</keyword>
  <keyword>Neurodegenerative disorder</keyword>
  <keyword>Imaging</keyword>
  <keyword>Prodromal</keyword>
  <keyword>Genetics</keyword>
  <keyword>At Risk</keyword>
  <keyword>Loss of Smell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson 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/NCT04507139
org study id: PPMI-004
nct id: NCT04507139
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Directly examine whether early (6-month) imaging with DaTscan and [¹⁸F] AV-133 will provide
      an early signal of disease progression in recently diagnosed untreated PD patients.
The study is a longitudinal, multi-center study to assess progression of DaTscan and [18F]
      AV-133 imaging in PD and Prodromal patients. Participants will be followed for up to 24
      months. Approximately 50 early PD participants and 100 Prodromal participants will be
      recruited from up to 15 sites. Participants will be comprehensively assessed at baseline and
      follow up according to the Schedule of Activities for the respective cohort. Participants
      will undergo imaging assessments with DaTscan and [18F] AV-133 and clinical (motor,
      neuropsychiatric and cognitive) assessments. Data will be collected by each site under
      uniformly established protocols and data will be stored and analyzed at designated core
      facilities.
observational model: Case-Only
time perspective: Other
measure: Mean Rate of Change
time frame: 24 months
description: The mean rates of change and the variability around the mean of imaging outcomes in early and Prodromal PD patients, and where appropriate the comparison of these rates between PD patient subsets at study intervals ranging from 6 months to 24 months. Specific examples of outcomes include dopamine transporter striatal uptake and vesicular monoamine transporter type-2 uptake. PD patient subsets may be defined by baseline assessments, genetic mutation, progression milestones and/or rate of clinical, imaging, or biomic change.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Institute for Neurodegenerative Disorders
investigator full name: Ken Marek, MD
investigator title: Protocol Principal Investigator
mesh term: Parkinson Disease