<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/NCT03232047</url>
  </required_header>
  <id_info>
    <org_study_id>Z161100000516001</org_study_id>
    <nct_id>NCT03232047</nct_id>
  </id_info>
  <brief_title>Computerized Cognitive Training for MCI</brief_title>
  <official_title>A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate whether memory training combined with executive&#xD;
      training could lead to improved cognitive and noncognitive performance in patients with MCI.&#xD;
      Furthermore, we will explore the neural correlates underlying the changed performances.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Mild cognitive impairment (MCI) is a clinical condition characterized of a reduction in&#xD;
      memory and/or other cognitive processes that are insufficiently severe to be diagnosed as&#xD;
      dementia, but are more pronounced than the cognitive decline associated with normal aging.&#xD;
      The prevalence of MCI ranges from 3% to 19% in adults older than 65 years; some of these&#xD;
      individuals seem to remain stable or return to normal over time, but more than half progress&#xD;
      to dementia within 5 years. Thus, MCI represents a critical window of opportunity for&#xD;
      intervening and altering the trajectory of both cognitive decline and loss of functional&#xD;
      independence in older adults. Cognitive function apart from memory such as executive function&#xD;
      is also impaired in patients with MCI. However, no study has yet placed sufficient emphasis&#xD;
      on the training of executive function.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The objective of the study is to evaluate whether memory training combined with executive&#xD;
      training could lead to improved cognitive and noncognitive performance in patients with MCI.&#xD;
      Furthermore, we will explore the neural correlates underlying the changed performances.&#xD;
&#xD;
      Patients and Methods:&#xD;
&#xD;
      The proposed study is a single blinded, randomized and controlled trial that will include 120&#xD;
      elderly patients with MCI from the memory clinic. The groups will be randomized to either&#xD;
      intervention or waiting-list group. The intervention is computerized combined memory and&#xD;
      executive function training performed for 60 minutes x 4 times/week over 26 weeks. A&#xD;
      neuropsychological assessment will be administered at baseline and week 4, 12 and 26 after&#xD;
      the intervention. The structural and functional MRI, EEG and NIRS will be performed at&#xD;
      baseline and week 26 after intervention for a sub-study on the effect of cognitive training&#xD;
      on brain structure and function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite working memory z score</measure>
    <time_frame>Change from baseline composite working memory z score at week 26</time_frame>
    <description>composite score of digit span and spatial span</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cognitive test package (CTP)</measure>
    <time_frame>Changes from baseline composite CTP score at week 26</time_frame>
    <description>composite score of episodic memory, speed processing, executive function, attention, language and social cognition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self evaluated memory ability</measure>
    <time_frame>Change from baseline self evaluated memory ability at week 26</time_frame>
    <description>Score on the questionnaire probes worries about memory (MMQ-contentment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Functional Imaging</measure>
    <time_frame>change from baseline functional connectivity at week 26</time_frame>
    <description>Brain function measured with MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical activity of the brain</measure>
    <time_frame>change from baseline electrical brain activity at week 26</time_frame>
    <description>Brain activity measured with electroencephalography (EEG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain structural imaging</measure>
    <time_frame>change from baseline cortical thickness at week 26</time_frame>
    <description>cortical thickness measured with MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral blood flow</measure>
    <time_frame>change from baseline cerebral blood flow at week 26</time_frame>
    <description>Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>Change from baseline composite mood score at week 26</time_frame>
    <description>composite score of mood status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDNF level</measure>
    <time_frame>change from baseline serum BDNF level at week 26</time_frame>
    <description>Serum Brain-derived neurotrophic factor (BDNF) level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of overall cognition z scores</measure>
    <time_frame>Changes from baseline composite overall cognition z score at week 26</time_frame>
    <description>Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Combined cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training is combined executive function and memory training. The training is considered 'adaptive', which means that the difficulty level of the tasks increases during the sessions according to the individual level of mastering for each participant, making the patient work at their maximum capacity at all times.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting-list group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control condition will conduct the same training as the intervention group after a 26-week waiting period. During the 26-week waiting period, the participants will receive assessment with the same protocol as the interventional group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Combined executive function and memory training</intervention_name>
    <description>Computerized combined executive function and memory training</description>
    <arm_group_label>Combined cognitive training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. An objective cognition impairment (a Montreal Cognitive Assessment (MoCA) score &lt; 26)&#xD;
&#xD;
          2. Preserved general cognitive function( an mini-mental state examination (MMSE) score of&#xD;
             &gt; 24)&#xD;
&#xD;
          3. Clinical Dementia Rating (CDR) = 0.5&#xD;
&#xD;
          4. Hamilton Depression Scale (HAMD) score of &lt; 12&#xD;
&#xD;
          5. Intact activities of daily living (ADL score of &lt;=26)&#xD;
&#xD;
          6. Schooling education &gt; = 5 years)&#xD;
&#xD;
          7. Not meeting the diagnosis of dementia (according to the 10th revision of the&#xD;
             International Statistical Classification of Diseases and Related Health Problems&#xD;
             (ICD-10) and the National Institute of Neurological and Communicative Disorders and&#xD;
             Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)&#xD;
             Probable Alzheimer's Criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious visual or hearing impairment;&#xD;
&#xD;
          2. Hachinski Ischemia Scale (HIS) &gt;= 4;&#xD;
&#xD;
          3. Subjects with Axis I disorders listed in the Diagnostic and Statistical Manual of&#xD;
             Mental Disorders, 4th Edition (DSM-IV), any other neurological disorders that could&#xD;
             affect cognitive function;&#xD;
&#xD;
          4. currently on titration of medications with cognitive enhancers or antidepressants;&#xD;
&#xD;
          5. having any physical condition that could preclude regular attendance and full&#xD;
             intervention-program participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huali Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Institute of Mental Health(Sixth hospital)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Huali Wang, MD</last_name>
    <phone>+86-10-82801983</phone>
    <email>huali_wang@bjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haifeng Zhang, MS</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Institute of Mental Health(Six Hospital)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haifeng Zhang, MS</last_name>
      <phone>86+18813185360</phone>
      <email>zhfphd@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Xiaozhen Lv, PhD</last_name>
      <phone>86+82801983</phone>
      <email>lxz120300@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Huali Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Haifeng Zhang, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Huali Wang</investigator_full_name>
    <investigator_title>Director of Clinical Research Division</investigator_title>
  </responsible_party>
  <keyword>Computerized, Executive function, memory, cognitive training</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_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/NCT03232047
org study id: Z161100000516001
nct id: NCT03232047
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to evaluate whether memory training combined with executive
      training could lead to improved cognitive and noncognitive performance in patients with MCI.
      Furthermore, we will explore the neural correlates underlying the changed performances.
Introduction:

      Mild cognitive impairment (MCI) is a clinical condition characterized of a reduction in
      memory and/or other cognitive processes that are insufficiently severe to be diagnosed as
      dementia, but are more pronounced than the cognitive decline associated with normal aging.
      The prevalence of MCI ranges from 3% to 19% in adults older than 65 years; some of these
      individuals seem to remain stable or return to normal over time, but more than half progress
      to dementia within 5 years. Thus, MCI represents a critical window of opportunity for
      intervening and altering the trajectory of both cognitive decline and loss of functional
      independence in older adults. Cognitive function apart from memory such as executive function
      is also impaired in patients with MCI. However, no study has yet placed sufficient emphasis
      on the training of executive function.

      Objectives:

      The objective of the study is to evaluate whether memory training combined with executive
      training could lead to improved cognitive and noncognitive performance in patients with MCI.
      Furthermore, we will explore the neural correlates underlying the changed performances.

      Patients and Methods:

      The proposed study is a single blinded, randomized and controlled trial that will include 120
      elderly patients with MCI from the memory clinic. The groups will be randomized to either
      intervention or waiting-list group. The intervention is computerized combined memory and
      executive function training performed for 60 minutes x 4 times/week over 26 weeks. A
      neuropsychological assessment will be administered at baseline and week 4, 12 and 26 after
      the intervention. The structural and functional MRI, EEG and NIRS will be performed at
      baseline and week 26 after intervention for a sub-study on the effect of cognitive training
      on brain structure and function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Composite working memory z score
time frame: Change from baseline composite working memory z score at week 26
description: composite score of digit span and spatial span
measure: cognitive test package (CTP)
time frame: Changes from baseline composite CTP score at week 26
description: composite score of episodic memory, speed processing, executive function, attention, language and social cognition
measure: Self evaluated memory ability
time frame: Change from baseline self evaluated memory ability at week 26
description: Score on the questionnaire probes worries about memory (MMQ-contentment).
measure: Brain Functional Imaging
time frame: change from baseline functional connectivity at week 26
description: Brain function measured with MRI.
measure: Electrical activity of the brain
time frame: change from baseline electrical brain activity at week 26
description: Brain activity measured with electroencephalography (EEG).
measure: Brain structural imaging
time frame: change from baseline cortical thickness at week 26
description: cortical thickness measured with MRI
measure: cerebral blood flow
time frame: change from baseline cerebral blood flow at week 26
description: Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).
measure: Mood
time frame: Change from baseline composite mood score at week 26
description: composite score of mood status
measure: BDNF level
time frame: change from baseline serum BDNF level at week 26
description: Serum Brain-derived neurotrophic factor (BDNF) level
measure: Composite of overall cognition z scores
time frame: Changes from baseline composite overall cognition z score at week 26
description: Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).
arm group label: Combined cognitive training
arm group type: Experimental
description: The training is combined executive function and memory training. The training is considered 'adaptive', which means that the difficulty level of the tasks increases during the sessions according to the individual level of mastering for each participant, making the patient work at their maximum capacity at all times.
arm group label: Waiting-list group
arm group type: No Intervention
description: Participants in the control condition will conduct the same training as the intervention group after a 26-week waiting period. During the 26-week waiting period, the participants will receive assessment with the same protocol as the interventional group.
intervention type: Device
intervention name: Combined executive function and memory training
description: Computerized combined executive function and memory training
arm group label: Combined cognitive training
criteria: 
gender: All
minimum age: 60 Years
maximum age: 89 Years
healthy volunteers: No
last name: Huali Wang, MD
role: Principal Investigator
affiliation: Peking University Institute of Mental Health(Sixth hospital)
last name: Huali Wang, MD
phone: +86-10-82801983
email: huali_wang@bjmu.edu.cn
last name: Haifeng Zhang, MS
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Huali Wang
investigator title: Director of Clinical Research Division
mesh term: Cognitive Dysfunction
sharing ipd: No