<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/NCT02225964</url>
  </required_header>
  <id_info>
    <org_study_id>XuanwuH 2</org_study_id>
    <nct_id>NCT02225964</nct_id>
  </id_info>
  <brief_title>Multi-modality MRI Study on Differences in Conversion of aMCI Patients With APOEε4 to AD</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>XuanwuH 2</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to find out the imaging marker and the changing laws of the marker during the&#xD;
      course of the disease. The final purpose is to provide scientific evidence for new&#xD;
      prevention, diagnosis and treatment of Alzheimer's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is an urgent problem in the field of cognitive neuroscience to tell the conversion&#xD;
      progression of amnestic mild cognitive impairment(aMCI) patients with&#xD;
      Apolipoproteinε4(APOEε4) to Alzheimer's Disease(AD). Based on our preliminary work, we will&#xD;
      study the special group of aMCI patients with APOEε4 with multi-modality magnetic resonance&#xD;
      imaging (resting-state functional MRI, structural MRI and diffusion tensor imaging)&#xD;
      longitudinally. Besides, we will also detect the APOE genotype of each sample and enlarge the&#xD;
      sample size. According to situation of the conversion or non-conversion and differences in&#xD;
      the conversion progression, we will analyze the data between the inter-groups and&#xD;
      intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging&#xD;
      marker of AD and optimize the reliability and validity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>the conversion of aMCI patients with APOEε4 to AD</measure>
    <time_frame>one year</time_frame>
    <description>According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>aMCIp,aMCIs</arm_group_label>
    <description>progressive aMCI,stable aMCI</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        aMCI patients with APOEε4&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Complaint about memory loss and confirmed by an informant&#xD;
&#xD;
          -  Cognitive impairment in single or multiple domains, adjusted for age and education&#xD;
&#xD;
          -  Normal or near-normal performance on general cognitive function and no or minimum&#xD;
             impairment of daily life activities&#xD;
&#xD;
          -  A Clinical Dementia Rating (CDR) score is 0.5&#xD;
&#xD;
          -  Failure to meet the criteria for dementia&#xD;
&#xD;
          -  Carrying susceptible gene APOEε4&#xD;
&#xD;
          -  Must be able to accept examination of MRI, sight and hearing allow to complete test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other diseases that cause cognitive impairment,such as thyroid disease,stroke and so&#xD;
             on&#xD;
&#xD;
          -  people who have severe visual and hearing impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neurolgy,Xuanwu Hospital of Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Xuanwu Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>XuanwuH 2</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <keyword>APOEε4</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT02225964
org study id: XuanwuH 2
nct id: NCT02225964
lead sponsor: 
collaborator: 
has dmc: Yes
This study is to find out the imaging marker and the changing laws of the marker during the
      course of the disease. The final purpose is to provide scientific evidence for new
      prevention, diagnosis and treatment of Alzheimer's disease.
It is an urgent problem in the field of cognitive neuroscience to tell the conversion
      progression of amnestic mild cognitive impairment(aMCI) patients with
      Apolipoproteinε4(APOEε4) to Alzheimer's Disease(AD). Based on our preliminary work, we will
      study the special group of aMCI patients with APOEε4 with multi-modality magnetic resonance
      imaging (resting-state functional MRI, structural MRI and diffusion tensor imaging)
      longitudinally. Besides, we will also detect the APOE genotype of each sample and enlarge the
      sample size. According to situation of the conversion or non-conversion and differences in
      the conversion progression, we will analyze the data between the inter-groups and
      intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging
      marker of AD and optimize the reliability and validity.
observational model: Cohort
time perspective: Prospective
measure: the conversion of aMCI patients with APOEε4 to AD
time frame: one year
description: According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.
arm group label: aMCIp,aMCIs
description: progressive aMCI,stable aMCI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Xuanwu Hospital, Beijing
investigator full name: XuanwuH 2
investigator title: Chief physician
mesh term: Cognitive Dysfunction