<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/NCT03251573</url>
  </required_header>
  <id_info>
    <org_study_id>Z161100002616005</org_study_id>
    <nct_id>NCT03251573</nct_id>
  </id_info>
  <brief_title>The Cohort Study of Cognitive Impairment in Chinese Hemodialysis Patients</brief_title>
  <acronym>CODE</acronym>
  <official_title>The Cohort Study of Cognitive Impairment and Its Association With Clinical Outcomes in Chinese Maintenance Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Shijitan Hospital, Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Shijitan Hospital, Capital Medical University</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>
      This study is going to apply neuropsychological battery tests to measure cognitive function&#xD;
      across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and&#xD;
      evaluate:&#xD;
&#xD;
        1. The presence and patterns of cognitive impairment in domains of executive function,&#xD;
           perceptual-motor function, language, learning and memory, and complex attention;&#xD;
&#xD;
        2. Clinical characteristics of participants with and without cognitive impairment;&#xD;
&#xD;
        3. the risk factors which might be related to cognitive impairment in this group of&#xD;
           population;&#xD;
&#xD;
        4. The association between cognitive impairment and all-cause mortality, stroke and&#xD;
           non-fatal cardiovascular events;&#xD;
&#xD;
      We hypothesize that hemodialysis patient is going to have cognitive impairment which might be&#xD;
      associated with some risk factors. We also anticipate that cognitive impairment might have&#xD;
      some kind of association with the clinical outcomes like all-cause mortality, stroke and&#xD;
      other common clinical outcomes that we mentioned above.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuropsychological assessment All neuropsychological assessments were performed by the&#xD;
      research staff that was centrally trained and certified by the study neuropsychologist to&#xD;
      conduct the assessments before study commencement. All research staff and patients were&#xD;
      native Chinese speakers. Neuropsychological assessment was conducted individually in a&#xD;
      separate room on the day after a dialysis session and required on average approximately 90&#xD;
      minutes. Global cognitive function was screened by the Chinese Beijing version of the&#xD;
      Montreal Cognitive Assessment (MoCA-BJ).10 The comprehensive battery of neuropsychological&#xD;
      tests was designed to assess five cognitive domains: (1) attention/processing speed, using&#xD;
      Symbol Digit Modalities Test and the Chinese modified version of the Trail Making Test&#xD;
      A,11,12(2) executive function, using the Chinese modified version of the Trail Making Tests B&#xD;
      , and a modified version of the Stroop Color-Word Test;13 (3) verbal memory, using the&#xD;
      Chinese version of the Auditory Verbal Learning Test for short-delay and long-delay free&#xD;
      recall14 and Complex Figure for visual memory (delayed recall test; Chinese version);12 (4)&#xD;
      language, using the Chinese modified versions of Boston Naming Test (the 30-item version) and&#xD;
      Animal Fluency Test;15,16and (5) visuospatial function, using the Rey-Osterrieth Complex&#xD;
      Figure (copy test).17,18 Depression was assessed using the Hamilton Depression Scale, with&#xD;
      scores ranging from 0 to 63 and a score of 7 or above suggested as the optimal cutoff for&#xD;
      suspected depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">June 18, 2019</completion_date>
  <primary_completion_date type="Actual">June 18, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>cognitive function</measure>
    <time_frame>This measurement is going to be completed within 3 months after the first participant enrolls.</time_frame>
    <description>This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">613</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Hemodialysis Complication</condition>
  <condition>Outcome</condition>
  <condition>Neuropsychological Tests</condition>
  <arm_group>
    <arm_group_label>Normal cognitive function</arm_group_label>
    <description>The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cognitive impairment</arm_group_label>
    <description>The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cognitive impairment</intervention_name>
    <description>one are of patients were exposed to cognitive impairment</description>
    <arm_group_label>cognitive impairment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese Maintenace Hemodialysis Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects have end-stage kidney disease and are treated with long-term outpatient&#xD;
             haemodialysis in each investigational site for at least the previous 3 months;&#xD;
&#xD;
          2. 50 ~ 80 years old;&#xD;
&#xD;
          3. willing to provide written and informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects have disturbance of consciousness or mental disorder;&#xD;
&#xD;
          2. Subjects have sensory (visual and hearing) or motor impairment, which disabled them to&#xD;
             complete the tests that required these senses;&#xD;
&#xD;
          3. Subjects have a life expectancy less than 6 months according to their physician, have&#xD;
             a planned kidney transplantation within 6 months of baseline, or have anticipated&#xD;
             recovery of kidney function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yang Luo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Shijitan Hospital Affiliated to Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Shijitan Hospital affiliated to Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>July 11, 2019</last_update_submitted>
  <last_update_submitted_qc>July 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Shijitan Hospital, Capital Medical University</investigator_affiliation>
    <investigator_full_name>Yang Luo, Chief, MD, PhD</investigator_full_name>
    <investigator_title>Director of nephrology</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>
  <pending_results>
    <submitted>February 15, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03251573
org study id: Z161100002616005
nct id: NCT03251573
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is going to apply neuropsychological battery tests to measure cognitive function
      across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and
      evaluate:

        1. The presence and patterns of cognitive impairment in domains of executive function,
           perceptual-motor function, language, learning and memory, and complex attention;

        2. Clinical characteristics of participants with and without cognitive impairment;

        3. the risk factors which might be related to cognitive impairment in this group of
           population;

        4. The association between cognitive impairment and all-cause mortality, stroke and
           non-fatal cardiovascular events;

      We hypothesize that hemodialysis patient is going to have cognitive impairment which might be
      associated with some risk factors. We also anticipate that cognitive impairment might have
      some kind of association with the clinical outcomes like all-cause mortality, stroke and
      other common clinical outcomes that we mentioned above.
Neuropsychological assessment All neuropsychological assessments were performed by the
      research staff that was centrally trained and certified by the study neuropsychologist to
      conduct the assessments before study commencement. All research staff and patients were
      native Chinese speakers. Neuropsychological assessment was conducted individually in a
      separate room on the day after a dialysis session and required on average approximately 90
      minutes. Global cognitive function was screened by the Chinese Beijing version of the
      Montreal Cognitive Assessment (MoCA-BJ).10 The comprehensive battery of neuropsychological
      tests was designed to assess five cognitive domains: (1) attention/processing speed, using
      Symbol Digit Modalities Test and the Chinese modified version of the Trail Making Test
      A,11,12(2) executive function, using the Chinese modified version of the Trail Making Tests B
      , and a modified version of the Stroop Color-Word Test;13 (3) verbal memory, using the
      Chinese version of the Auditory Verbal Learning Test for short-delay and long-delay free
      recall14 and Complex Figure for visual memory (delayed recall test; Chinese version);12 (4)
      language, using the Chinese modified versions of Boston Naming Test (the 30-item version) and
      Animal Fluency Test;15,16and (5) visuospatial function, using the Rey-Osterrieth Complex
      Figure (copy test).17,18 Depression was assessed using the Hamilton Depression Scale, with
      scores ranging from 0 to 63 and a score of 7 or above suggested as the optimal cutoff for
      suspected depression.
observational model: Cohort
time perspective: Prospective
measure: cognitive function
time frame: This measurement is going to be completed within 3 months after the first participant enrolls.
description: This study is going to apply neuropsychological battery tests to measure cognitive function across multiple cognitive domains
arm group label: Normal cognitive function
description: The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively
arm group label: cognitive impairment
description: The cognitive impairment classification algorithm We classified subjects as having no, mild, or major cognitive impairment using criteria from the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as a guideline.20 The age and/or education-adjusted raw score of each individual cognitive test was calculated and compared with the age and/or education-adjusted published norms for Chinese populations.14 Specifically, age- and education-adjusted scores less than 1.5 standard deviations (SDs) below the adjusted mean of the published population norms on all tests in all domains indicated no cognitive impairment; scores of 1.50 to 1.99 SDs and 2.0 or more SDs below the adjusted mean of the published norms on at least one test in at least one domain indicated mild cognitive impairment and major cognitive impairment, respectively
intervention type: Other
intervention name: cognitive impairment
description: one are of patients were exposed to cognitive impairment
arm group label: cognitive impairment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yang Luo, MD, PhD
role: Principal Investigator
affiliation: Beijing Shijitan Hospital Affiliated to Capital Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Shijitan Hospital, Capital Medical University
investigator full name: Yang Luo, Chief, MD, PhD
investigator title: Director of nephrology
mesh term: Cognitive Dysfunction
submitted: February 15, 2023