<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/NCT01705327</url>
  </required_header>
  <id_info>
    <org_study_id>BioFIND</org_study_id>
    <nct_id>NCT01705327</nct_id>
  </id_info>
  <brief_title>Fox Investigation for New Discovery of Biomarkers</brief_title>
  <acronym>BioFIND</acronym>
  <official_title>Fox Investigation for New Discovery of Biomarkers (BioFIND)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael J. Fox Foundation for Parkinson's Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Michael J. Fox Foundation for Parkinson's Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational, multi-center study to assess clinical features and biologic&#xD;
      biomarkers in Parkinson's disease (PD) patients compared to healthy controls (HC). The&#xD;
      primary objective of this study is to discover clinical and biologic markers of PD for use in&#xD;
      clinical trials of disease-modifying therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BioFIND is a two-year observational clinical study designed to discover and verify biomarkers&#xD;
      of Parkinson's disease (PD). BioFIND is collecting clinical data and biospecimens, including&#xD;
      blood and cerebrospinal fluid (CSF), in a population of 120 well-defined, moderately advanced&#xD;
      PD subjects and 120 healthy controls.&#xD;
&#xD;
      BioFIND will follow standardized data acquisition protocols to ensure that tests and&#xD;
      assessments conducted at multiple sites can be pooled. Data and samples acquired from study&#xD;
      participants will enable the development of a comprehensive Parkinson's database and&#xD;
      biorepository, which will be available to the scientific community to conduct research on&#xD;
      novel PD biomarkers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>No primary outcome measure</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Parkinson's Disease Subjects</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control Subjects</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cerebrospinal Fluid (CSF), whole blood, DNA, plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Parkinson's disease and healthy control subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (PD Subjects):&#xD;
&#xD;
          -  Subjects must have bradykinesia and rigidity.&#xD;
&#xD;
          -  Current or history of well documented resting tremor.&#xD;
&#xD;
          -  Unilateral onset or persistent asymmetry.&#xD;
&#xD;
          -  A well established response to dopaminergic agents including the presence of levodopa&#xD;
             induced dyskinesia for at least 3 years according to treating physician's judgment.&#xD;
&#xD;
          -  Subject has progressive PD of 5 to 18 years of duration from the onset of symptoms.&#xD;
&#xD;
          -  Male or female age of onset of PD 50 to 70 by history. Current ages would range from&#xD;
             55 to 93 based on #5 and #6 requirements.&#xD;
&#xD;
          -  Ability to provide written informed consent in accordance with Good Clinical Practice&#xD;
             (GCP), International Conference on Harmonization (ICH), and local regulations.&#xD;
&#xD;
          -  Willing and able to comply with scheduled visits, required study procedures and&#xD;
             laboratory tests.&#xD;
&#xD;
        Exclusion Criteria (PD Subjects):&#xD;
&#xD;
          -  Family history of PD in first degree relatives.&#xD;
&#xD;
          -  Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will&#xD;
             be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA),&#xD;
             unless these have been already excluded by genetic testing.&#xD;
&#xD;
          -  Has others serious neurological disorders (clinically significant stroke, brain tumor,&#xD;
             hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated&#xD;
             head trauma).&#xD;
&#xD;
          -  Has early severe autonomic involvement. Symptomatic orthostatic, hypotension or&#xD;
             urinary incontinence within one year of onset of disease symptom.&#xD;
&#xD;
          -  Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude&#xD;
             safe completion of the lumbar puncture.&#xD;
&#xD;
          -  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;
          -  Any other medical or psychiatric condition or lab abnormality, which in the opinion of&#xD;
             the investigator might preclude participation.&#xD;
&#xD;
          -  Use of investigational drugs or devices within 60 days prior to baseline (dietary&#xD;
             supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme&#xD;
             Q10).&#xD;
&#xD;
          -  Has lower body predominant symptoms.&#xD;
&#xD;
          -  Has supra-nuclear gaze palsy, CG sign, corticospinal track signs.&#xD;
&#xD;
        Inclusion Criteria (HC Subjects):&#xD;
&#xD;
          -  Male or female age 55 to 93 years at visit 1.&#xD;
&#xD;
          -  Ability to provide written informed consent in accordance with Good Clinical Practice&#xD;
             (GCP), International Conference on Harmonization (ICH), and local regulations.&#xD;
&#xD;
          -  Willing and able to comply with scheduled visits, required study procedures and&#xD;
             laboratory tests.&#xD;
&#xD;
        Exclusion Criteria (HC Subjects):&#xD;
&#xD;
          -  Family history of PD in first degree relatives.&#xD;
&#xD;
          -  Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will&#xD;
             be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA),&#xD;
             unless these have been already excluded by genetic testing.&#xD;
&#xD;
          -  Has other serious neurological disorders (clinically significant stroke, brain tumor,&#xD;
             hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated&#xD;
             head trauma).&#xD;
&#xD;
          -  Has a history of cancer, autoimmune disorder, liver disease, or hematological&#xD;
             disorders within the past 5 years.&#xD;
&#xD;
          -  Has early severe autonomic involvement: symptomatic orthostatic hypotension or urinary&#xD;
             incontinence within one year of onset of disease symptom.&#xD;
&#xD;
          -  Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude&#xD;
             safe completion of the lumbar puncture.&#xD;
&#xD;
          -  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;
          -  Any other medical or psychiatric condition or lab abnormality, which in the opinion of&#xD;
             the investigator might preclude participation.&#xD;
&#xD;
          -  Use of investigational drugs or devices within 60 days prior to baseline (dietary&#xD;
             supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme&#xD;
             Q10).&#xD;
&#xD;
          -  MoCA score &lt;26.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>93 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Goldman, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roy Alcalay, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Claire Henchcliffe, MD, D. Phil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Well Cornell Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tao Xie, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Tuite, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Un Jung Kang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cindy Casaceli, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trial Coordinating Center, University of Rochester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Penelope Hogarth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samuel A. Frank, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amy Amara, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornell University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 2, 2015</last_update_submitted>
  <last_update_submitted_qc>October 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Neurodegenerative disorder</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/NCT01705327
org study id: BioFIND
nct id: NCT01705327
lead sponsor: 
collaborator: 
has dmc: No
This is an observational, multi-center study to assess clinical features and biologic
      biomarkers in Parkinson's disease (PD) patients compared to healthy controls (HC). The
      primary objective of this study is to discover clinical and biologic markers of PD for use in
      clinical trials of disease-modifying therapies.
BioFIND is a two-year observational clinical study designed to discover and verify biomarkers
      of Parkinson's disease (PD). BioFIND is collecting clinical data and biospecimens, including
      blood and cerebrospinal fluid (CSF), in a population of 120 well-defined, moderately advanced
      PD subjects and 120 healthy controls.

      BioFIND will follow standardized data acquisition protocols to ensure that tests and
      assessments conducted at multiple sites can be pooled. Data and samples acquired from study
      participants will enable the development of a comprehensive Parkinson's database and
      biorepository, which will be available to the scientific community to conduct research on
      novel PD biomarkers.
observational model: Cohort
time perspective: Cross-Sectional
measure: No primary outcome measure
time frame: Two years
arm group label: Parkinson's Disease Subjects
arm group label: Healthy Control Subjects
Cerebrospinal Fluid (CSF), whole blood, DNA, plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 93 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Goldman, MD, MS
role: Principal Investigator
affiliation: Rush University Medical Center
last name: Roy Alcalay, MD, MS
role: Principal Investigator
affiliation: Columbia University
last name: Claire Henchcliffe, MD, D. Phil
role: Principal Investigator
affiliation: Well Cornell Medical Center
last name: Tao Xie, MD, PhD
role: Principal Investigator
affiliation: University of Chicago
last name: Paul Tuite, MD
role: Principal Investigator
affiliation: University of Minnesota Medical Center
last name: Un Jung Kang, MD
role: Study Chair
affiliation: University of Chicago
last name: Cindy Casaceli, MBA
role: Principal Investigator
affiliation: Clinical Trial Coordinating Center, University of Rochester
last name: Penelope Hogarth, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: Samuel A. Frank, MD
role: Principal Investigator
affiliation: Boston Medical Center
last name: Amy Amara, MD, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease