<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/NCT03773185</url>
  </required_header>
  <id_info>
    <org_study_id>2018.454</org_study_id>
    <nct_id>NCT03773185</nct_id>
  </id_info>
  <brief_title>A Comparative Study of Brain Structure and Amyloid Load in MCI Patients</brief_title>
  <official_title>A Comparative Study of Brain Structure and Amyloid Load Between Cognitively Impaired Older People With or Without Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Older people with DM are at greater risk of cognitive decline than their counterparts with&#xD;
      DM. Cognitive impairment in older people with DM may be associated with non-AD related brain&#xD;
      atrophy and white matter disease. The investigators therefore propose to compare DM and&#xD;
      non-DM older people with amnesic MCI in brian volumes, white matter disease and amyloid load.&#xD;
&#xD;
      30 older people with aMCI, 30 older people with aMCI and DM, age 65-85 will be recruited.&#xD;
      They all will have amyloid PET scan and MRI brain scan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Low recruitment rate&#xD;
  </why_stopped>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Amyloid load</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <eligibility>
    <study_pop>
      <textblock>
        MCI patients with DM or without DM&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MCI patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with depression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy Kwok, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Timothy Kwok</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03773185
org study id: 2018.454
nct id: NCT03773185
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Older people with DM are at greater risk of cognitive decline than their counterparts with
      DM. Cognitive impairment in older people with DM may be associated with non-AD related brain
      atrophy and white matter disease. The investigators therefore propose to compare DM and
      non-DM older people with amnesic MCI in brian volumes, white matter disease and amyloid load.

      30 older people with aMCI, 30 older people with aMCI and DM, age 65-85 will be recruited.
      They all will have amyloid PET scan and MRI brain scan.
observational model: Cohort
time perspective: Cross-Sectional
measure: Amyloid load
time frame: Two years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: Timothy Kwok, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Timothy Kwok
investigator title: Professor
mesh term: Cognitive Dysfunction