xml: <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/NCT06005935</url>
    </required_header>
    <id_info>
      <org_study_id>805745</org_study_id>
      <nct_id>NCT06005935</nct_id>
    </id_info>
    <brief_title>Environmental and Reproductive Health Risk for Lewy Body Dementia</brief_title>
    <acronym>LBD-TOROS</acronym>
    <official_title>Sex-Specific Environmental and Reproductive Health Risk Factors for Lewy Body Dementia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Diego</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Lewy Body Dementia Association (LBDA)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Diego</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this survey study is to identify environmental, occupational and reproductive&#xD;
        health risk factors for Lewy body dementia, which includes Parkinson's disease dementia and&#xD;
        dementia with Lewy bodies. Participants will complete a one-time survey online or over the&#xD;
        phone that includes questions on environmental, occupational factors they may have been&#xD;
        exposed to and on medical history including reproductive health. Researchers will then&#xD;
        compare the responses of people with Lewy body dementia and people without Parkinson's or&#xD;
        memory/thinking problems to see which factors play a role in Lewy body dementia. Identifying&#xD;
        risk factors can guide future treatment efforts and provide more insight to this dementia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lewy body dementia, including Parkinson's disease dementia and dementia with Lewy bodies, is&#xD;
        one of the most common dementias and does not have a cure for now. It can occur differently&#xD;
        for women and men, although we are not sure why. The ratio of women to men for the disease&#xD;
        prevalence changes with older age, suggesting a potential role for reproductive factors,&#xD;
        particularly for women. Environmental factors impact the risk for other types of dementia,&#xD;
        although such factors have not been clearly described in Lewy body dementia specifically.&#xD;
        Women and men may get exposed to different environmental and occupational risk factors, and&#xD;
        the impact of factors can differ for women and men. By using one-time survey that can be&#xD;
        completed online or over the phone, we will try to understand which environmental,&#xD;
        occupational or reproductive health factors play a role in Lewy body dementia for women and&#xD;
        men. By comparing the survey responses of people with Lewy body dementia and people without&#xD;
        Parkinson's or memory/thinking problems, we aim to identify specific risk factors for women&#xD;
        and men that can guide future treatment efforts and provide more insight into this dementia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>Environmental, occupational, reproductive health factors</measure>
      <time_frame>1 year</time_frame>
      <description>Responses of participants with Lewy body dementia and controls completing the survey including questions on environmental, occupational and reproductive health factors will be compared to determine which factors play a role in Lewy body dementia.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Lewy Body Dementia</condition>
    <condition>Parkinson Disease Dementia</condition>
    <condition>Dementia With Lewy Bodies</condition>
    <arm_group>
      <arm_group_label>Participants with Lewy body dementia</arm_group_label>
      <description>50 women and 50 men with a clinical diagnosis of Lewy body dementia (Parkinson's disease dementia or dementia with Lewy bodies) will be included. If assistance is needed to complete the survey, care partners can help, however, they cannot answer the questions on the participant's behalf without the participant's contribution.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls</arm_group_label>
      <description>50 women and 50 men with normal cognition and without Parkinson's disease will be included. Normal cognition will be determined using a screening questionnaire in the beginning of the survey to determine eligibility.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey</intervention_name>
      <description>Participants will complete a one-time survey including questions on demographics, health status, reproductive health history, environmental and occupational factors one may or may not have been exposed to. The survey can be completed online or over the phone, and should last approximately 30-45 minutes.</description>
      <arm_group_label>Controls</arm_group_label>
      <arm_group_label>Participants with Lewy body dementia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants with Lewy body dementia will include 50 women and 50 men with a clinical&#xD;
          diagnosis of Lewy body dementia (Parkinson's disease dementia or dementia with Lewy&#xD;
          bodies). If assistance is needed to complete the survey, care partners can help, however,&#xD;
          they cannot answer the questions on the participant's behalf without the participant's&#xD;
          contribution. Controls will include 50 women and 50 men with similar age as the&#xD;
          participants with Lewy body dementia. Normal cognition will be determined using a screening&#xD;
          questionnaire in the beginning of the survey to determine eligibility.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For participants with Lewy body dementia: Clinical diagnosis of Lewy body dementia&#xD;
               (Parkinson's disease dementia or dementia with Lewy bodies)&#xD;
  &#xD;
            -  For controls: Normal cognition&#xD;
  &#xD;
            -  Implication of consent to participate by stating consent verbally over the phone or by&#xD;
               selecting the appropriate response on the online survey to indicate consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For controls: Parkinson's disease or dementia diagnosis&#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>Ece Bayram, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Diego</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hamidreza Ghodsi, MD</last_name>
      <phone>858-213-3069</phone>
      <email>hghodsi@health.ucsd.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ece Bayram, MD, PhD</last_name>
      <phone>858-246-2546</phone>
      <email>ebayram@health.ucsd.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California San Diego</name>
        <address>
          <city>La Jolla</city>
          <state>California</state>
          <zip>92093</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hamidreza Ghodsi, MD</last_name>
        <phone>858-213-3069</phone>
        <email>hghodsi@health.ucsd.edu</email>
      </contact>
      <contact_backup>
        <last_name>Ece Bayram, MD, PhD</last_name>
        <phone>8582462546</phone>
        <email>ebayram@health.ucsd.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Ece Bayram, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://redcap.link/LBDTOROS</url>
      <description>Link to find out more and participate in the online survey</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, San Diego</investigator_affiliation>
      <investigator_full_name>Ece Bayram</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Dementia</mesh_term>
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Lewy Body Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005935
  org study id: 805745
  nct id: NCT06005935
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this survey study is to identify environmental, occupational and reproductive
        health risk factors for Lewy body dementia, which includes Parkinson's disease dementia and
        dementia with Lewy bodies. Participants will complete a one-time survey online or over the
        phone that includes questions on environmental, occupational factors they may have been
        exposed to and on medical history including reproductive health. Researchers will then
        compare the responses of people with Lewy body dementia and people without Parkinson's or
        memory/thinking problems to see which factors play a role in Lewy body dementia. Identifying
        risk factors can guide future treatment efforts and provide more insight to this dementia.
  Lewy body dementia, including Parkinson's disease dementia and dementia with Lewy bodies, is
        one of the most common dementias and does not have a cure for now. It can occur differently
        for women and men, although we are not sure why. The ratio of women to men for the disease
        prevalence changes with older age, suggesting a potential role for reproductive factors,
        particularly for women. Environmental factors impact the risk for other types of dementia,
        although such factors have not been clearly described in Lewy body dementia specifically.
        Women and men may get exposed to different environmental and occupational risk factors, and
        the impact of factors can differ for women and men. By using one-time survey that can be
        completed online or over the phone, we will try to understand which environmental,
        occupational or reproductive health factors play a role in Lewy body dementia for women and
        men. By comparing the survey responses of people with Lewy body dementia and people without
        Parkinson's or memory/thinking problems, we aim to identify specific risk factors for women
        and men that can guide future treatment efforts and provide more insight into this dementia.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Environmental, occupational, reproductive health factors
  time frame: 1 year
  description: Responses of participants with Lewy body dementia and controls completing the survey including questions on environmental, occupational and reproductive health factors will be compared to determine which factors play a role in Lewy body dementia.
  arm group label: Participants with Lewy body dementia
  description: 50 women and 50 men with a clinical diagnosis of Lewy body dementia (Parkinson's disease dementia or dementia with Lewy bodies) will be included. If assistance is needed to complete the survey, care partners can help, however, they cannot answer the questions on the participant's behalf without the participant's contribution.
  arm group label: Controls
  description: 50 women and 50 men with normal cognition and without Parkinson's disease will be included. Normal cognition will be determined using a screening questionnaire in the beginning of the survey to determine eligibility.
  intervention type: Other
  intervention name: Survey
  description: Participants will complete a one-time survey including questions on demographics, health status, reproductive health history, environmental and occupational factors one may or may not have been exposed to. The survey can be completed online or over the phone, and should last approximately 30-45 minutes.
  arm group label: Controls
  arm group label: Participants with Lewy body dementia
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ece Bayram, MD, PhD
  role: Principal Investigator
  affiliation: University of California, San Diego
  last name: Hamidreza Ghodsi, MD
  phone: 858-213-3069
  email: hghodsi@health.ucsd.edu
  last name: Ece Bayram, MD, PhD
  phone: 858-246-2546
  email: ebayram@health.ucsd.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  url: https://redcap.link/LBDTOROS
  description: Link to find out more and participate in the online survey
  responsible party type: Principal Investigator
  investigator affiliation: University of California, San Diego
  investigator full name: Ece Bayram
  investigator title: Principal Investigator
  mesh term: Parkinson Disease
  mesh term: Dementia
  mesh term: Alzheimer Disease
  mesh term: Lewy Body Disease
  sharing ipd: No