<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/NCT01730599</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-11-NG-0473</org_study_id>
    <nct_id>NCT01730599</nct_id>
  </id_info>
  <brief_title>A Longitudinal Study in Parkinson's Disease (PD) Patients</brief_title>
  <official_title>A Longitudinal 5 Years Follow up Study in Parkinson's Disease (PD) Patients Carriers of the LRRK2 Gene G2019S Mutation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic&#xD;
      mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat&#xD;
      kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between&#xD;
      genetic mutations in the known genes and their influence on disease manifestation over few&#xD;
      years of follow up&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in updrs motor and total scores</measure>
    <time_frame>the participants will be followed for 5 years. the measurements will be taken evry 18 month.</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>PD patients</arm_group_label>
    <description>PD patients carriers of the G2019S mutation in the LRRK2 gene</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neurological exam</intervention_name>
    <description>motor and cognitive functions</description>
    <arm_group_label>PD patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        PD patients carriers of the G2019S mutation in the LRRK2 gene&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parkinson'd disease patients that already participated in a pasr cross sectional study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with cognitive decline by the parameters defined in Diagnostic and&#xD;
             Statistical Manual of Mental Disorders (DSM)- IV&#xD;
&#xD;
          -  subjects with psychiatric disorder&#xD;
&#xD;
          -  subjects unable to sign a consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anat Mirelman, PhD</last_name>
    <phone>972-3-6973014</phone>
    <email>anatmi@tasmc.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Anat Mirelman, PhD</last_name>
      <phone>972-3-6973014</phone>
      <email>anatmi@tasmc.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 15, 2012</last_update_submitted>
  <last_update_submitted_qc>November 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</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>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/NCT01730599
org study id: TASMC-11-NG-0473
nct id: NCT01730599
lead sponsor: 
has dmc: No
This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic
      mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat
      kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between
      genetic mutations in the known genes and their influence on disease manifestation over few
      years of follow up
observational model: Cohort
measure: change from baseline in updrs motor and total scores
time frame: the participants will be followed for 5 years. the measurements will be taken evry 18 month.
arm group label: PD patients
description: PD patients carriers of the G2019S mutation in the LRRK2 gene
intervention type: Other
intervention name: neurological exam
description: motor and cognitive functions
arm group label: PD patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Anat Mirelman, PhD
phone: 972-3-6973014
email: anatmi@tasmc.health.gov.il
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Parkinson Disease