<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/NCT04477785</url>
  </required_header>
  <id_info>
    <org_study_id>PPMI-002</org_study_id>
    <nct_id>NCT04477785</nct_id>
  </id_info>
  <brief_title>PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort</brief_title>
  <acronym>PPMI</acronym>
  <official_title>The Parkinson's Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael J. Fox Foundation for Parkinson's Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute for Neurodegenerative Disorders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Michael J. Fox Foundation for Parkinson's Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,&#xD;
      multi-center natural history study to assess progression of clinical features, digital&#xD;
      outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression&#xD;
      in study participants with manifest PD, prodromal PD, and healthy controls.&#xD;
&#xD;
      The overall goal of PPMI is to identify markers of disease progression for use in clinical&#xD;
      trials of therapies to reduce progression of PD disability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PPMI is a broad program, expanding the goals of the original PPMI study, that includes this&#xD;
      PPMI Clinical protocol, as well as other program initiatives such as the PPMI Remote, PPMI&#xD;
      Digital App and PPMI Online protocols. Participants in PPMI may be asked to be enrolled in&#xD;
      other PPMI program protocols, but depending on their method of recruitment, participants may&#xD;
      be enrolled sequentially in varying order, as appropriate. PPMI participants may also be&#xD;
      asked to participate in additional PPMI program initiatives (as they are developed), which&#xD;
      may only involve a subset of PPMI participants based on their cohort designation and/or site&#xD;
      location.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 2033</completion_date>
  <primary_completion_date type="Anticipated">December 2033</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Establish standardized protocols for acquisition, transfer and analysis of clinical, digital, imaging, biologic and genetic data that can be used by the PD research community.</measure>
    <time_frame>Baseline to 156 months</time_frame>
    <description>This protocol will build on the existing PPMI infrastructure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comprehensive and uniformly acquired dataset</measure>
    <time_frame>Baseline to 156 months</time_frame>
    <description>Develop a comprehensive and uniformly acquired clinical, digital and imaging dataset and repository of biological and genetic samples that would be available to the PD research community to test hypotheses of the underlying molecular pathobiology of PD, enable modeling of PD progression to identify clinical and/or data driven PD progression sub-sets, and inform studies testing PD therapeutics (for examples, clinical trials targeting synuclein, LRRK2, GBA as well as other targets)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison between Rates of Change</measure>
    <time_frame>Study intervals ranging from 3 months to 156 months</time_frame>
    <description>Use clinical and biological data to estimate the mean rates of change and the variability around the mean of clinical, digital, imaging, biological and genetic outcomes in study participants with PD diagnosis (including patients with a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and individuals with prodromal Parkinson's disease (including individuals with REM sleep behavior disorder (RBD)), olfactory loss, LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/or other risk factors for PD with and without dopamine transporter (DAT) deficit and in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of measures of clinical, imaging and biomic outcomes in various subsets</measure>
    <time_frame>study intervals ranging from baseline to 156 months.</time_frame>
    <description>Confirm existing and identify novel clinical, digital, imaging, biologic and genetic PD progression markers to identify quantitative individual measures or combinations of measures that demonstrate optimum interval change in study participants with PD diagnosis (including patients with a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1)) and individuals with prodromal Parkinson's disease (including individuals with RBD, olfactory loss, a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/or other risk factors for PD with and without DAT deficit in comparison to healthy controls or in sub-sets of study participants with PD diagnosis or prodromal PD defined by baseline assessments, progression milestones and/or rate of clinical, digital, imaging, biologic and genetic change, or other measures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Establish the probability of phenoconversion to PD</measure>
    <time_frame>study intervals ranging from baseline to 156 months.</time_frame>
    <description>Evaluate the probability of phenoconversion to PD for individuals with prodromal PD enrolled in the prodromal cohorts (including individuals with RBD, olfactory loss, a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/ or other risk factors for PD with and without DAT deficit).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">4500</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Clinical Observation</arm_group_label>
    <description>In PPMI Clinical up to 4,500 participants will be enrolled and followed longitudinally once identified, over the course of 5-8 years.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood will be obtained for the extraction of DNA to conduct sequencing and genomic analysis.&#xD;
      These maybe collected in a fasted state.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In PPMI Clinical up to 4,500 participants will be enrolled and followed longitudinally from&#xD;
        approximately 50-55 international clinical sites across a variety of cohorts, including&#xD;
        healthy controls, Parkinson disease, PD manifesting gene carriers, and Prodromal (those at&#xD;
        risk for developing PD).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        7.1 Healthy Controls (HC) Note: Active Healthy controls previously enrolled in PPMI do not&#xD;
        require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical.&#xD;
        Active participants do need to be able to provide informed consent for PPMI Clinical&#xD;
        participation (includes use of a designated research proxy).&#xD;
&#xD;
        7.1.1 Inclusion Criteria (HC)&#xD;
&#xD;
          1. Male or female age 57 years or older at Screening visit.&#xD;
&#xD;
          2. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,&#xD;
             amphetamine derivatives or modafinil, must be willing and medically able to hold the&#xD;
             medication for at least 5 half-lives before SPECT imaging.&#xD;
&#xD;
          3. Confirmation that participant is eligible based on Screening SPECT imaging.&#xD;
&#xD;
          4. Able to provide informed consent.&#xD;
&#xD;
          5. Either is male, or is female and meets additional criteria below, as applicable:&#xD;
&#xD;
               -  Female of childbearing potential who is not pregnant, lactating, or planning&#xD;
                  pregnancy during the study and has a negative pregnancy test on day of Screening&#xD;
                  SPECT imaging test prior to injection of DaTscanTM.&#xD;
&#xD;
        7.1.2 Exclusion Criteria (HC)&#xD;
&#xD;
          1. First degree relative with PD (i.e., biologic parent, sibling, child).&#xD;
&#xD;
          2. Current or active clinically significant neurological disorder (in the opinion of the&#xD;
             Investigator).&#xD;
&#xD;
          3. Previously obtained MRI scan with evidence of clinically significant neurological&#xD;
             disorder (in the opinion of the Investigator).&#xD;
&#xD;
          4. Received any of the following drugs: dopamine receptor blockers (neuroleptics),&#xD;
             metoclopramide and reserpine within 6 months of Screening visit.&#xD;
&#xD;
          5. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin&#xD;
             inhibitors) that might preclude safe completion of the lumbar puncture.&#xD;
&#xD;
          6. Condition that precludes the safe performance of routine lumbar puncture, such as&#xD;
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant&#xD;
             coagulopathy or thrombocytopenia.&#xD;
&#xD;
          7. Any other medical or psychiatric condition or lab abnormality, which in the opinion of&#xD;
             the investigator might preclude participation.&#xD;
&#xD;
          8. Any other reason that, in the opinion of the investigator, would render the&#xD;
             participant unsuitable for study enrollment.&#xD;
&#xD;
        7.2 Parkinson's Disease (PD) Note: Active PD participants previously enrolled in PPMI do&#xD;
        not require re-assessment of eligibility criteria listed below for enrollment in PPMI&#xD;
        Clinical. Active participants do need to be able to provide informed consent for PPMI&#xD;
        Clinical participation (includes use of a designated research proxy).&#xD;
&#xD;
        7.2.1 Inclusion Criteria (PD)&#xD;
&#xD;
          1. Male or female age 30 years or older at Screening Visit.&#xD;
&#xD;
          2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.&#xD;
&#xD;
          3. Not expected to require PD medication within at least 6 months from Baseline.&#xD;
&#xD;
          4. Patients must have at least two of the following: resting tremor, bradykinesia,&#xD;
             rigidity (must have either resting tremor or bradykinesia); OR either asymmetric&#xD;
             resting tremor or asymmetric bradykinesia.&#xD;
&#xD;
          5. Hoehn and Yahr stage I or II at Baseline.&#xD;
&#xD;
          6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,&#xD;
             amphetamine derivatives or modafinil, must be willing and medically able to hold the&#xD;
             medication for at least 5 half-lives before SPECT imaging.&#xD;
&#xD;
          7. Confirmation that participant is eligible based on Screening SPECT imaging.&#xD;
&#xD;
          8. Able to provide informed consent.&#xD;
&#xD;
          9. Either is male, or is female and meets additional criteria below, as applicable:&#xD;
&#xD;
               -  Female of childbearing potential who is not pregnant, lactating, or planning&#xD;
                  pregnancy during the study and has a negative pregnancy test on day of Screening&#xD;
                  SPECT imaging test prior to injection of DaTscanTM.&#xD;
&#xD;
        7.2.2 Exclusion Criteria (PD)&#xD;
&#xD;
          1. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another&#xD;
             PD medication, except for low-dose treatment of restless leg syndrome (with permission&#xD;
             of medical monitor).&#xD;
&#xD;
          2. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days&#xD;
             of Baseline visit.&#xD;
&#xD;
          3. Has taken levodopa or dopamine agonists prior to Baseline visit for more than a total&#xD;
             of 90 days.&#xD;
&#xD;
          4. Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine,&#xD;
             neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or&#xD;
             degenerative diseases (e.g., progressive supranuclear palsy).&#xD;
&#xD;
          5. A clinical diagnosis of dementia as determined by the investigator.&#xD;
&#xD;
          6. Previously obtained MRI scan with evidence of clinically significant neurological&#xD;
             disorder (in the opinion of the Investigator).&#xD;
&#xD;
          7. Received any of the following drugs: dopamine receptor blockers (neuroleptics),&#xD;
             metoclopramide and reserpine within 6 months of Screening visit.&#xD;
&#xD;
          8. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin&#xD;
             inhibitors) that might preclude safe completion of the lumbar puncture.&#xD;
&#xD;
          9. Condition that precludes the safe performance of routine lumbar puncture, such as&#xD;
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant&#xD;
             coagulopathy or thrombocytopenia.&#xD;
&#xD;
         10. Any other medical or psychiatric condition or lab abnormality, which in the opinion of&#xD;
             the investigator might preclude participation.&#xD;
&#xD;
         11. Any other reason that, in the opinion of the investigator, would render the&#xD;
             participant unsuitable for study enrollment.&#xD;
&#xD;
        7.3 Parkinson's Disease (PD) with LRRK2 or GBA variant Note: Active PD participants&#xD;
        previously enrolled in PPMI do not require re-assessment of eligibility criteria listed&#xD;
        below for enrollment in PPMI Clinical. Active participants do need to be able to provide&#xD;
        informed consent for PPMI Clinical participation (includes use of a designated research&#xD;
        proxy).&#xD;
&#xD;
        7.3.1 Inclusion Criteria (PD ¬- LRRK2 or GBA)&#xD;
&#xD;
          1. Male or female age 30 years or older at Screening Visit.&#xD;
&#xD;
          2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.&#xD;
&#xD;
          3. Patients must have at least two of the following: resting tremor, bradykinesia,&#xD;
             rigidity (must have either resting tremor or bradykinesia); OR either asymmetric&#xD;
             resting tremor or asymmetric bradykinesia.&#xD;
&#xD;
          4. Hoehn and Yahr stage I or II at Baseline.&#xD;
&#xD;
          5. Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part&#xD;
             of genetic screening and be informed of genetic testing results, or approved&#xD;
             documentation of prior genetic testing results).&#xD;
&#xD;
          6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,&#xD;
             amphetamine derivatives or modafinil, must be willing and medically able to hold the&#xD;
             medication for at least 5 half-lives before SPECT imaging.&#xD;
&#xD;
          7. Confirmation that participant is eligible based on Screening SPECT imaging.&#xD;
&#xD;
          8. Able to provide informed consent.&#xD;
&#xD;
          9. Either is male, or is female and meets additional criteria below, as applicable:&#xD;
&#xD;
               -  Female of childbearing potential who is not pregnant, lactating, or planning&#xD;
                  pregnancy during the study and has a negative pregnancy test on day of Screening&#xD;
                  SPECT imaging test prior to injection of DaTscanTM.&#xD;
&#xD;
        7.3.2 Exclusion Criteria (PD - LRRK2 or GBA)&#xD;
&#xD;
          1. Received any of the following drugs: dopamine receptor blockers (neuroleptics),&#xD;
             metoclopramide and reserpine within 6 months of Screening visit.&#xD;
&#xD;
          2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude&#xD;
             safe completion of the lumbar puncture.&#xD;
&#xD;
          3. Condition that precludes the safe performance of routine lumbar puncture, such as&#xD;
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant&#xD;
             coagulopathy or thrombocytopenia.&#xD;
&#xD;
          4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of&#xD;
             the investigator might preclude participation.&#xD;
&#xD;
          5. Any other reason that, in the opinion of the investigator, would render the&#xD;
             participant unsuitable for study enrollment.&#xD;
&#xD;
        7.4 Parkinson's Disease (PD) with SNCA or rare genetic variant Note: Active PD participants&#xD;
        previously enrolled in PPMI do not require re-assessment of eligibility criteria listed&#xD;
        below for enrollment in PPMI clinical. Active participants do need to be able to provide&#xD;
        informed consent for PPMI Clinical participation (includes use of a designated research&#xD;
        proxy).&#xD;
&#xD;
        7.4.1 Inclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))&#xD;
&#xD;
          1. Male or female age 30 years or older at Screening Visit.&#xD;
&#xD;
          2. Parkinson's disease diagnosis at Screening Visit.&#xD;
&#xD;
          3. Patients must have at least two of the following: resting tremor, bradykinesia,&#xD;
             rigidity (must have either resting tremor or bradykinesia); OR either asymmetric&#xD;
             resting tremor or asymmetric bradykinesia.&#xD;
&#xD;
          4. Hoehn and Yahr stage I, II, or III at Baseline.&#xD;
&#xD;
          5. Confirmation of causative SNCA or rare genetic variant (such as Parkin or Pink1)&#xD;
             (willingness to undergo genetic testing as part of genetic screening and be informed&#xD;
             of genetic testing results, or approved documentation of prior genetic testing&#xD;
             results).&#xD;
&#xD;
          6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,&#xD;
             amphetamine derivatives or modafinil, must be willing and medically able to hold the&#xD;
             medication for at least 5 half-lives before SPECT imaging.&#xD;
&#xD;
          7. Confirmation that participant is eligible based on Screening SPECT imaging.&#xD;
&#xD;
          8. Able to provide informed consent.&#xD;
&#xD;
          9. Either is male, or is female and meets additional criteria below, as applicable:&#xD;
&#xD;
               -  Female of childbearing potential who is not pregnant, lactating, or planning&#xD;
                  pregnancy during the study and has a negative pregnancy test on day of Screening&#xD;
                  SPECT imaging test prior to injection of DaTscanTM.&#xD;
&#xD;
        7.4.2 Exclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))&#xD;
&#xD;
          1. Received any of the following drugs: dopamine receptor blockers (neuroleptics),&#xD;
             metoclopramide and reserpine within 6 months of Screening visit.&#xD;
&#xD;
          2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude&#xD;
             safe completion of the lumbar puncture.&#xD;
&#xD;
          3. Condition that precludes the safe performance of routine lumbar puncture, such as&#xD;
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant&#xD;
             coagulopathy or thrombocytopenia.&#xD;
&#xD;
          4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of&#xD;
             the investigator might preclude participation.&#xD;
&#xD;
          5. Any other reason that, in the opinion of the investigator, would render the&#xD;
             participant unsuitable for study enrollment.&#xD;
&#xD;
        7.5 Prodromal Note: Active Prodromal participants previously enrolled in PPMI do not&#xD;
        require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical.&#xD;
        Active participants do need to be able to provide informed consent for PPMI Clinical&#xD;
        participation (includes use of a designated research proxy).&#xD;
&#xD;
        The specific predictive eligibility criteria for participants recruited through PPMI Remote&#xD;
        to advance to PPMI Clinical will be iteratively optimized based on data collected from&#xD;
        these studies.&#xD;
&#xD;
        7.5.1 Inclusion criteria (Prodromal)&#xD;
&#xD;
        For Screening:&#xD;
&#xD;
          1. Confirmation that participant is eligible based on centrally determined predictive&#xD;
             criteria including the University of Pennsylvania Smell Identification Test (UPSIT).&#xD;
&#xD;
               -  For participants in PPMI Remote, referral to the clinical site confirms&#xD;
                  predictive eligibility.&#xD;
&#xD;
               -  For participants identified by the clinical site, predictive criteria are based&#xD;
                  on generalized risk such as first degree biologic relative, known risk of PD&#xD;
                  including RBD, or known genetic variants associated with PD risk.&#xD;
&#xD;
             Additionally, confirmation of UPSIT eligibility during the Screening visit prior to&#xD;
             SPECT Imaging.&#xD;
&#xD;
          2. Male or female age 60 years or older (except age 30 years or older for SNCA, or rare&#xD;
             genetic variants (such as Parkin or Pink1) participants).&#xD;
&#xD;
          3. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,&#xD;
             amphetamine derivatives or modafinil, must be willing and medically able to hold the&#xD;
             medication for at least 5 half-lives before SPECT imaging.&#xD;
&#xD;
          4. Able to provide informed consent.&#xD;
&#xD;
          5. Either is male, or is female and meets additional criteria below, as applicable:&#xD;
&#xD;
             • Female of childbearing potential who is not pregnant, lactating, or planning&#xD;
             pregnancy during the study and has a negative pregnancy test on day of Screening SPECT&#xD;
             imaging test prior to injection of DaTscanTM.&#xD;
&#xD;
             For continuation to Baseline visit and ongoing follow-up:&#xD;
&#xD;
          6. Confirmation that participant is eligible based on *Screening SPECT imaging.&#xD;
&#xD;
               -  Screening SPECT Imaging eligibility:&#xD;
&#xD;
        Based on the results of the SPECT imaging test, Prodromal participants eligible to continue&#xD;
        their participation in PPMI Clinical will be asked to return for their PPMI Clinical&#xD;
        baseline visit. Neither the participant nor the site investigator will be made aware of the&#xD;
        participant's DAT status during the study.&#xD;
&#xD;
          -  It is anticipated that approximately 6,000 participants will complete a screening&#xD;
             visit to undergo DAT imaging. Approximately 2,000 participants will be eligible to&#xD;
             continue their participation in PPMI Clinical (those not eligible to proceed will&#xD;
             remain in PPMI Remote, as applicable).&#xD;
&#xD;
          -  All participants with DAT deficit will be eligible to continue their participation in&#xD;
             PPMI Clinical. It is estimated that about 75% of eligible participants will have a DAT&#xD;
             deficit (defined by a hybrid of visual assessment and quantitative striatal specific&#xD;
             binding analysis).&#xD;
&#xD;
          -  Some participants without DAT deficit will also be eligible to continue their&#xD;
             participation in PPMI Clinical. These participants will be chosen based on DAT binding&#xD;
             that is reduced from age expected but it not outside the normal range and/or from&#xD;
             individuals with high-risk of PD including RBD, LRRK2, GBA, SNCA, or rare genetic&#xD;
             variants (such as Parkin or Pink1) that do not demonstrate DAT deficit. It is&#xD;
             estimated that about 25% of eligible participants will not have a DAT deficit.&#xD;
&#xD;
          -  It is anticipated that approximately 30% of the PPMI Clinical prodromal participants&#xD;
             with DAT deficit will phenoconvert to motor parkinsonism during a 3 to 5-year&#xD;
             follow-up.&#xD;
&#xD;
        7.5.2 Exclusion Criteria (Prodromal)&#xD;
&#xD;
          1. Clinical diagnosis of PD at screening, other parkinsonism, or dementia.&#xD;
&#xD;
          2. Received any of the following drugs: dopamine receptor blockers (neuroleptics),&#xD;
             metoclopramide and reserpine within 6 months of Baseline Visit.&#xD;
&#xD;
          3. Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude&#xD;
             safe completion of the lumbar puncture.&#xD;
&#xD;
          4. Condition that precludes the safe performance of routine lumbar puncture, such as&#xD;
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant&#xD;
             coagulopathy or thrombocytopenia.&#xD;
&#xD;
          5. Any other medical or psychiatric condition or lab abnormality, which in the opinion of&#xD;
             the investigator might preclude participation.&#xD;
&#xD;
          6. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another&#xD;
             PD medication, except for low-dose treatment of restless leg syndrome (with permission&#xD;
             of medical monitor).&#xD;
&#xD;
          7. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days&#xD;
             of Baseline visit. except for low-dose treatment of restless leg syndrome (with&#xD;
             permission of medical monitor).&#xD;
&#xD;
          8. Any other reason that, in the opinion of the investigator, would render the&#xD;
             participant unsuitable for study enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth L Marek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Neurodegenerative Disorders</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Caroline Tanner, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cari Rainville, BS</last_name>
    <phone>877-525-7764</phone>
    <email>crainville@indd.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Victor Sung, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Standaert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barrow Neurological Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Holly Shill, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Foundation for Medical Education and Research</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Charles Adler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Banner Research Institute</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Sara Dhanani, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Shprecher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0948</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
      <email>clinicaltrialsadrc@health.ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>Douglas Galasko, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Keck School of Medicine of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Mark Lew</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Caroline Tanner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Maureen Leehey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <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>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>David Russell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Parkinson's Disease&amp; Movement Disorder Center of Boca Raton</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Stuart Isaacson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Nikolaus McFarland</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Robert Hauser, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Stewart A Factor, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Tanya Simuni, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Rajesh Pahwa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Emile Moukheiber, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Marie H. Saint-Hilaire, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02446</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Aleksandar Videnovic, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Kelvin Chou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Lou Ruvo Center for Brain Health</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Zoltan Mari, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beth Israel Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Susan Bressman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Un Kang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giulietta Riboldi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Karen Marder, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Ruth Schneider, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati/Cincinnati Children's Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Alberto Espay, MD, MSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Hubert H. Fernandez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp;Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Penelope Hogarth, MD</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>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Nabila Dahodwala, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Lana Chahine, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Arjun Tarakad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Univ of Washington and VA Puget Sound Health Care System</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Shu-Ching Hu, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Innsbruck Medical University</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corrine Horlings</last_name>
    </contact>
    <investigator>
      <last_name>Werner Poewe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital - Civic Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Tiago Mestre</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Connie Marras</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>McGill University</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3A2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PPMI Call Center</last_name>
      <phone>877-525-7764</phone>
    </contact>
    <investigator>
      <last_name>Ron Postuma</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Philipps-University of Marburg</name>
      <address>
        <city>Hessen</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabeth Sittig</last_name>
      <email>sittig@med.uni-marburg.de</email>
    </contact>
    <investigator>
      <last_name>Wolfgang Oertel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Paracelsus-Elena Klinik</name>
      <address>
        <city>Kassel</city>
        <zip>34128</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diana Willeke</last_name>
      <phone>49 561 6009 272</phone>
      <email>diana.willeke@pk-mx.de</email>
    </contact>
    <investigator>
      <last_name>Brit Mollenhauer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Luebeck</name>
      <address>
        <city>Luebeck</city>
        <zip>23562</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Norbert Bruggermann</last_name>
      <email>norbert.brueggemann@neuro.uni-luebeck.de</email>
    </contact>
    <investigator>
      <last_name>Christine Klein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ella Hilt</last_name>
      <phone>+49 7072 298621</phone>
      <email>ella.hilt@med.uni-tuebingen.de</email>
    </contact>
    <investigator>
      <last_name>Isabel Wurster, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kathrin Brockmann</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Foundation for Biomedical Research of the Academy of Athens</name>
      <address>
        <city>Athens</city>
        <zip>11523</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christos Koros</last_name>
      <phone>00302107289405</phone>
      <email>chkoros@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Leonidas Stefanis, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anat Mirelman, Bsc</last_name>
      <phone>972-3-697-3014</phone>
      <email>anatmi@tlvmc.gov.il</email>
    </contact>
    <investigator>
      <last_name>Nir Giladi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Salerno</name>
      <address>
        <city>Salerno</city>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Ainscough, BA</last_name>
      <phone>39 340 519 2659</phone>
      <email>ricercaparkinson@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Paolo Barone, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Luxembourg</name>
      <address>
        <city>Esch-sur-Alzette</city>
        <zip>L-4367</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tainá Marques</last_name>
      <phone>352(466)644-6491</phone>
      <email>taina.marques@ext.uni.lu</email>
    </contact>
    <investigator>
      <last_name>Rejko Krueger</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Radboud University</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6525 GC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Myrthe Burgler</last_name>
      <email>myrthe.burgler@radboudumc.nl</email>
    </contact>
    <investigator>
      <last_name>Baastian Bloem</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lagos College of Medicine, University of Lagos</name>
      <address>
        <city>Lagos</city>
        <zip>121010</zip>
        <country>Nigeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oluwadamilola Ojo</last_name>
      <phone>2348033606414</phone>
      <email>oluojo@unilag.edu.ng</email>
    </contact>
    <investigator>
      <last_name>Njideka Okubadejo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alicia Garrido, MD</last_name>
      <phone>34 932275785</phone>
      <email>agarridop@clinic.ub.es</email>
    </contact>
    <investigator>
      <last_name>Eduardo Tolosa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria Jose Marti</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Donostia</name>
      <address>
        <city>San Sebastian</city>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ioana Croitoru</last_name>
      <phone>+34 943 00 72 46</phone>
      <email>ioana.croitoru@biodonostia.org</email>
    </contact>
    <investigator>
      <last_name>Javier Ruiz Martinez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Mary University of London</name>
      <address>
        <city>London</city>
        <state>Britain</state>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cristina Simonet</last_name>
      <phone>44-02078823379</phone>
      <email>c.simonet@qmul.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Cristina Simonet</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alastair Noyce</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Newcastle University</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <state>Tyne And Wear</state>
        <zip>NE45PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victoria Foster</last_name>
      <phone>+441912081197</phone>
      <email>victoria.foster@ncl.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Nicola Pavese</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Ledingham</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Imperial College London</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raquel Lopes</last_name>
      <email>raquel.lopes@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Yen Tai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital Oxford and Oxford University</name>
      <address>
        <city>Oxford</city>
        <zip>Oxford, OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jamil Razzaque</last_name>
      <phone>+441865223166</phone>
      <email>jamil.razzaque@ouh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Michele Hu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Luxembourg</country>
    <country>Netherlands</country>
    <country>Nigeria</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Norway</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 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 Co- 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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04477785
org study id: PPMI-002
nct id: NCT04477785
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,
      multi-center natural history study to assess progression of clinical features, digital
      outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression
      in study participants with manifest PD, prodromal PD, and healthy controls.

      The overall goal of PPMI is to identify markers of disease progression for use in clinical
      trials of therapies to reduce progression of PD disability.
PPMI is a broad program, expanding the goals of the original PPMI study, that includes this
      PPMI Clinical protocol, as well as other program initiatives such as the PPMI Remote, PPMI
      Digital App and PPMI Online protocols. Participants in PPMI may be asked to be enrolled in
      other PPMI program protocols, but depending on their method of recruitment, participants may
      be enrolled sequentially in varying order, as appropriate. PPMI participants may also be
      asked to participate in additional PPMI program initiatives (as they are developed), which
      may only involve a subset of PPMI participants based on their cohort designation and/or site
      location.
observational model: Case-Control
time perspective: Other
measure: Establish standardized protocols for acquisition, transfer and analysis of clinical, digital, imaging, biologic and genetic data that can be used by the PD research community.
time frame: Baseline to 156 months
description: This protocol will build on the existing PPMI infrastructure
measure: Comprehensive and uniformly acquired dataset
time frame: Baseline to 156 months
description: Develop a comprehensive and uniformly acquired clinical, digital and imaging dataset and repository of biological and genetic samples that would be available to the PD research community to test hypotheses of the underlying molecular pathobiology of PD, enable modeling of PD progression to identify clinical and/or data driven PD progression sub-sets, and inform studies testing PD therapeutics (for examples, clinical trials targeting synuclein, LRRK2, GBA as well as other targets)
measure: Comparison between Rates of Change
time frame: Study intervals ranging from 3 months to 156 months
description: Use clinical and biological data to estimate the mean rates of change and the variability around the mean of clinical, digital, imaging, biological and genetic outcomes in study participants with PD diagnosis (including patients with a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and individuals with prodromal Parkinson's disease (including individuals with REM sleep behavior disorder (RBD)), olfactory loss, LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/or other risk factors for PD with and without dopamine transporter (DAT) deficit and in healthy participants.
measure: Prevalence of measures of clinical, imaging and biomic outcomes in various subsets
time frame: study intervals ranging from baseline to 156 months.
description: Confirm existing and identify novel clinical, digital, imaging, biologic and genetic PD progression markers to identify quantitative individual measures or combinations of measures that demonstrate optimum interval change in study participants with PD diagnosis (including patients with a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1)) and individuals with prodromal Parkinson's disease (including individuals with RBD, olfactory loss, a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/or other risk factors for PD with and without DAT deficit in comparison to healthy controls or in sub-sets of study participants with PD diagnosis or prodromal PD defined by baseline assessments, progression milestones and/or rate of clinical, digital, imaging, biologic and genetic change, or other measures.
measure: Establish the probability of phenoconversion to PD
time frame: study intervals ranging from baseline to 156 months.
description: Evaluate the probability of phenoconversion to PD for individuals with prodromal PD enrolled in the prodromal cohorts (including individuals with RBD, olfactory loss, a LRRK2, GBA, SNCA or rare genetic variants (such as Parkin or Pink1) and/ or other risk factors for PD with and without DAT deficit).
arm group label: Clinical Observation
description: In PPMI Clinical up to 4,500 participants will be enrolled and followed longitudinally once identified, over the course of 5-8 years.
Blood will be obtained for the extraction of DNA to conduct sequencing and genomic analysis.
      These maybe collected in a fasted state.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth L Marek, MD
role: Principal Investigator
affiliation: Institute for Neurodegenerative Disorders
last name: Caroline Tanner, MD, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Cari Rainville, BS
phone: 877-525-7764
email: crainville@indd.org
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country: Austria
country: Canada
country: Germany
country: Greece
country: Israel
country: Italy
country: Luxembourg
country: Netherlands
country: Nigeria
country: Spain
country: United Kingdom
country: United States
country: France
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Institute for Neurodegenerative Disorders
investigator full name: Ken Marek, MD
investigator title: Protocol Co- Principal Investigator
mesh term: Parkinson Disease
sharing ipd: Undecided