<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/NCT04436848</url>
  </required_header>
  <id_info>
    <org_study_id>UMG2385R</org_study_id>
    <nct_id>NCT04436848</nct_id>
  </id_info>
  <brief_title>LRRK2 G2385R Leucocyte and Urine Biomarker Study</brief_title>
  <acronym>LRRK2 G2385R</acronym>
  <official_title>Identifying Leucocyte and Urine Biomarkers in Parkinson's Patients With LRRK2 G2385R Gene Variant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Michael J. Fox Foundation for Parkinson's Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Dundee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nextcea, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Max Planck Institute of Biochemistry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Malaya</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>
      Given the emerging evidence on LRRK2-related biomarkers, this project will focus on&#xD;
      identifying leucocyte and urine biomarkers that are altered by the LRRK2 G2385R variant, and&#xD;
      investigating the effects of LRRK2 kinase inhibitor (MLi-2) on these biomarkers, using&#xD;
      immunoblotting and mass spectrometry.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of monocyte-based biomarkers for LRRK2 G2385R variant</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of urine-based biomarkers for LRRK2 G2385R variant</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>PD patients positive for LRRK2 G2385R</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>PD patients negative for LRRK2 G2385R</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-PD controls negative for LRRK2 G2385R</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>This is a non-interventional study</intervention_name>
    <description>This is a non-interventional study</description>
    <arm_group_label>Non-PD controls negative for LRRK2 G2385R</arm_group_label>
    <arm_group_label>PD patients negative for LRRK2 G2385R</arm_group_label>
    <arm_group_label>PD patients positive for LRRK2 G2385R</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples for extraction of DNA, monocytes and serum Urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Parkinson's disease attending the Neurology outpatient clinic, at University&#xD;
        of Malaya Medical Centre, Kuala Lumpur, Malaysia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Parkinson's disease assigned by a movement disorder specialist according&#xD;
             to clinical diagnostic criteria&#xD;
&#xD;
          -  Age above 18 year-old&#xD;
&#xD;
          -  Provision of a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Physical or mental incapacity to complete study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ai Huey Tan, MD, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaya</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ai Huey Tan, MD, FRCP</last_name>
    <phone>60379492891</phone>
    <email>aihuey.tan@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shen Yang Lim, MD, FRACP</last_name>
    <phone>60379492891</phone>
    <email>limshenyang@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50603</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ai Huey Tan</last_name>
      <phone>60379492891</phone>
      <email>aihuey.tan@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Shen Yang Lim</last_name>
      <phone>60379492891</phone>
      <email>limshenyang@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Lei Cheng Lit, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Azlina Ahmad Annuar, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yet Hoi Hong, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified clinical data will be kept for storage at a central repository either hosted by the funder (Michael J. Fox Foundation), its collaborators, or consultants and will be made publicly available (with no personal identifying information) for the intended use of research in Parkinson's disease as well as other biomedical research studies that may not be related to Parkinson's disease.</ipd_description>
  </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/NCT04436848
org study id: UMG2385R
nct id: NCT04436848
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Given the emerging evidence on LRRK2-related biomarkers, this project will focus on
      identifying leucocyte and urine biomarkers that are altered by the LRRK2 G2385R variant, and
      investigating the effects of LRRK2 kinase inhibitor (MLi-2) on these biomarkers, using
      immunoblotting and mass spectrometry.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Identification of monocyte-based biomarkers for LRRK2 G2385R variant
time frame: Two years
measure: Identification of urine-based biomarkers for LRRK2 G2385R variant
time frame: Two years
arm group label: PD patients positive for LRRK2 G2385R
arm group label: PD patients negative for LRRK2 G2385R
arm group label: Non-PD controls negative for LRRK2 G2385R
intervention type: Other
intervention name: This is a non-interventional study
description: This is a non-interventional study
arm group label: Non-PD controls negative for LRRK2 G2385R
arm group label: PD patients negative for LRRK2 G2385R
arm group label: PD patients positive for LRRK2 G2385R
Blood samples for extraction of DNA, monocytes and serum Urine samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ai Huey Tan, MD, FRCP
role: Principal Investigator
affiliation: University of Malaya
last name: Ai Huey Tan, MD, FRCP
phone: 60379492891
email: aihuey.tan@gmail.com
last name: Shen Yang Lim, MD, FRACP
phone: 60379492891
email: limshenyang@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Malaysia
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Yes
ipd description: De-identified clinical data will be kept for storage at a central repository either hosted by the funder (Michael J. Fox Foundation), its collaborators, or consultants and will be made publicly available (with no personal identifying information) for the intended use of research in Parkinson's disease as well as other biomedical research studies that may not be related to Parkinson's disease.