<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/NCT02198586</url>
  </required_header>
  <id_info>
    <org_study_id>MRI/FBB 2014</org_study_id>
    <nct_id>NCT02198586</nct_id>
  </id_info>
  <brief_title>Apoe Impact Study on Brain Structure and Function, in a Population 45 to 75 Years Old</brief_title>
  <official_title>Apoe Impact Study on Brain Structure and Function, in a Population 45 to 75 Years Old</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barcelonabeta Brain Research Center, Pasqual Maragall Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barcelonabeta Brain Research Center, Pasqual Maragall Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the influence of the APOE genotype on brain&#xD;
      morphology, function and metabolism, related to other factors such as cognitive reserve,&#xD;
      cognition and episodic memory, in subjects at greater risk of developing AD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the influence of age and the APOE genotype on&#xD;
      brain morphology and function, in 700 cognitively healthy individuals, 45 to 75 years old,&#xD;
      recruited from an ongoing longitudinal cognition study exploring memory and executive&#xD;
      functions (ClinicalTrials.gov ID: NCT01835717).&#xD;
&#xD;
      All subjects have been APOE genotyped and underwent a clinical and cognitive assessment.&#xD;
      Within this study, the subjects will be submitted to an MRI scanning protocol including&#xD;
      morphological and resting state acquisitions. An identical follow-up MRI session will be&#xD;
      performed in 2 years' time. The analyses will be focused on detecting the effect of the APOE&#xD;
      allelic variants on the change rate of the neuroimaging variables as well as its interaction&#xD;
      with aging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">July 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hippocampal atrophy</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">575</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <description>The population of this study is 45 to 75 years old at the time of inclusion in the parent study (ClinicalTrials.gov ID: NCT01835717).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The population of this study is 45 to 75 years old at the time of inclusion in the parent&#xD;
        study (ClinicalTrials.gov ID: NCT01835717), mostly sons and daughters of AD patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant included in the study ClinicalTrials.gov ID: NCT01835717&#xD;
&#xD;
          -  APOE genotype obtained before MRI acquisition&#xD;
&#xD;
          -  Be willing to perform an MRI and agree to a 2 years longitudinal follow up&#xD;
&#xD;
          -  Sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to MRI scanning: claustrophobia, pacemaker, history of ocular&#xD;
             cerclage, heart valves, aneurysm clips and carrying any metal prosthesis incompatible&#xD;
             with MRI.&#xD;
&#xD;
          -  Incidental MRI findings that result in the images not being included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan D Gispert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barcelonabeta Brain Research Center, Pasqual Maragall Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José L Molinuevo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IDIBAPS, Hospital Clinic de Barcelona, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barcelonabeta Brain Research Center</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://fpmaragall.org/en/</url>
    <description>Main home page</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's, MRI, APOE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer 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/NCT02198586
org study id: MRI/FBB 2014
nct id: NCT02198586
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the influence of the APOE genotype on brain
      morphology, function and metabolism, related to other factors such as cognitive reserve,
      cognition and episodic memory, in subjects at greater risk of developing AD.
The purpose of this study is to investigate the influence of age and the APOE genotype on
      brain morphology and function, in 700 cognitively healthy individuals, 45 to 75 years old,
      recruited from an ongoing longitudinal cognition study exploring memory and executive
      functions (ClinicalTrials.gov ID: NCT01835717).

      All subjects have been APOE genotyped and underwent a clinical and cognitive assessment.
      Within this study, the subjects will be submitted to an MRI scanning protocol including
      morphological and resting state acquisitions. An identical follow-up MRI session will be
      performed in 2 years' time. The analyses will be focused on detecting the effect of the APOE
      allelic variants on the change rate of the neuroimaging variables as well as its interaction
      with aging.
observational model: Cohort
time perspective: Prospective
measure: Hippocampal atrophy
time frame: 2 years
arm group label: No treatment
description: The population of this study is 45 to 75 years old at the time of inclusion in the parent study (ClinicalTrials.gov ID: NCT01835717).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juan D Gispert, PhD
role: Principal Investigator
affiliation: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
last name: José L Molinuevo, MD, PhD
role: Principal Investigator
affiliation: IDIBAPS, Hospital Clinic de Barcelona, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
facility: 
country: Spain
url: https://fpmaragall.org/en/
description: Main home page
responsible party type: Sponsor
mesh term: Alzheimer Disease