<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/NCT03821857</url>
  </required_header>
  <id_info>
    <org_study_id>18-008476</org_study_id>
    <secondary_id>U54AG044170-09</secondary_id>
    <nct_id>NCT03821857</nct_id>
  </id_info>
  <brief_title>Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease</brief_title>
  <official_title>Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researchers are trying to determine whether ovarian hormones are associated with aging&#xD;
      processes and with the risk of developing Alzheimer's disease in women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed project will enroll 200 women. Each women will have one clinic visit consisting&#xD;
      of cognitive testing, tests of physical function, questionnaires, and a blood draw. All women&#xD;
      will also undergo clinical neuroimaging, which includes structural MRI, β-amyloid (Aβ)&#xD;
      deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of&#xD;
      neurofibrillary tangles using AV-1451.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 27, 2019</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>18F-Flortaucipir PET imaging</measure>
    <time_frame>1 day</time_frame>
    <description>Cortical 18F-Flortaucipir PET imaging measured once in each participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pittsburgh compound-B PET imaging</measure>
    <time_frame>1 day</time_frame>
    <description>Global cortical SUVR measured once in each participant</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18-F-Flortaucipir</intervention_name>
    <description>Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology</description>
    <arm_group_label>Women</arm_group_label>
    <other_name>11C-Pittsburgh Compound-B</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who lived in Olmsted County, Minnesota between 1988 and 2007&#xD;
&#xD;
          -  Currently aged 55 years and older&#xD;
&#xD;
          -  More than six months post chemotherapy or major surgery requiring general anesthesia&#xD;
&#xD;
          -  Willing and able to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to read and speak English&#xD;
&#xD;
          -  In hospice&#xD;
&#xD;
          -  Claustrophobic&#xD;
&#xD;
          -  If undergoing Tau imaging, cannot have QT Prolongation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kejal Kantarci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 5, 2023</last_update_submitted>
  <last_update_submitted_qc>June 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kejal Kantarci</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>Alzheimer Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Corticosterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03821857
org study id: 18-008476
secondary id: U54AG044170-09
nct id: NCT03821857
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The researchers are trying to determine whether ovarian hormones are associated with aging
      processes and with the risk of developing Alzheimer's disease in women.
The proposed project will enroll 200 women. Each women will have one clinic visit consisting
      of cognitive testing, tests of physical function, questionnaires, and a blood draw. All women
      will also undergo clinical neuroimaging, which includes structural MRI, β-amyloid (Aβ)
      deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of
      neurofibrillary tangles using AV-1451.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 18F-Flortaucipir PET imaging
time frame: 1 day
description: Cortical 18F-Flortaucipir PET imaging measured once in each participant
measure: Pittsburgh compound-B PET imaging
time frame: 1 day
description: Global cortical SUVR measured once in each participant
arm group label: Women
arm group type: Experimental
description: 18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology
intervention type: Drug
intervention name: 18-F-Flortaucipir
description: Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology
arm group label: Women
other name: 11C-Pittsburgh Compound-B
criteria: 
gender: Female
gender based: Yes
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Kejal Kantarci, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kejal Kantarci
investigator title: Principal Investigator
mesh term: Alzheimer Disease
mesh term: Corticosterone
sharing ipd: No