<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/NCT01688128</url>
  </required_header>
  <id_info>
    <org_study_id>E-1207/162-001</org_study_id>
    <nct_id>NCT01688128</nct_id>
  </id_info>
  <brief_title>Efficacy of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART)</brief_title>
  <acronym>U-SMART</acronym>
  <official_title>An Open-label, Controlled, Cross-over Trial of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART) in Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KT Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based&#xD;
      Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild&#xD;
      cognitive impairment (MCI) by an open-label, controlled, crossover Trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which&#xD;
      consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on&#xD;
      the spaced retrieval training (SRT), which was effective in improving memory retention span&#xD;
      of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by&#xD;
      transforming the current SMART to a self-administered program using an application working on&#xD;
      IPAD was developed, and showed its feasibility and efficacy in the elderly individuals with&#xD;
      mild cognitive impairment in the preliminary study. (ClinicalTrials.gov ID: NCT01628653) To&#xD;
      validate the efficacy of the U-SMART, an open-label, controlled, crossover design of clinical&#xD;
      trial were planned in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Word List Test (memory, recall, recognition) of the CERAD Neuropsychological Assessment Battery before and after phase I intervention and before and after phase II intervention (crossover part of the study)</measure>
    <time_frame>Baseline, 5 weeks, 11weeks</time_frame>
    <description>To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT), Word List Recall Test (WLRT), Word List Recognition Test (WLRcT) of the CERAD neuropsychological assessment battery were applied to all participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Subjective Memory Complaints Questionnaire (SMCQ) before and after phase I intervention and before and after phase II intervention (crossover part of the study)</measure>
    <time_frame>Baseline, 5 weeks, 11weeks</time_frame>
    <description>To evaluate the subjective memory improvement after the U-SMART, the Subjective Memory Complaints Questionnaire(SMCQ) was applied to all participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Geriatric Depression Scale (GDS) before and after phase I intervention and before and after phase II intervention (crossover part of the study)</measure>
    <time_frame>Baseline, 5 weeks, 11weeks</time_frame>
    <description>To evaluate the subjective mood after the U-SMART, the Geriatric Depression Scale was applied to all participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Mini-Mental State Examination before and after phase I intervention and before and after phase II intervention (crossover part of the study)</measure>
    <time_frame>Baseline, 5 weeks, 11weeks</time_frame>
    <description>To evaluate the global cognitive function after the U-SMART, the Mini-Mental State Examination was applied to all participants.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Intervention_Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control_Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phase I U-SMART (4 wks)</intervention_name>
    <description>Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention</description>
    <arm_group_label>Intervention_Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Washout (2 wks)</intervention_name>
    <description>2-weeks wash out period in both arms</description>
    <arm_group_label>Control_Intervention group</arm_group_label>
    <arm_group_label>Intervention_Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phase II U-SMART (4 wks)</intervention_name>
    <description>Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)</description>
    <arm_group_label>Control_Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 55-90&#xD;
&#xD;
          -  Educational level above 1 year and confirmed literacy&#xD;
&#xD;
          -  Diagnosed to mild cognitive impairment by International Working Group on Mild&#xD;
             Cognitive Impairment&#xD;
&#xD;
          -  Clinical Dementia Rating (CDR) of 0 or 0.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed to dementia by DSM-IV&#xD;
&#xD;
          -  Evidence of delirium, confusion&#xD;
&#xD;
          -  Any neurological conditions causing cognitive decline such as Parkinson's disease,&#xD;
             brain hemorrhage, brain tumor, normal pressure hydrocephalus&#xD;
&#xD;
          -  Evidence of severe cerebrovascular pathology&#xD;
&#xD;
          -  History of loss-of-consciousness over 1 hour due to head trauma or repetitive head&#xD;
             trauma of mild severity&#xD;
&#xD;
          -  History of substance abuse or dependence such as alcohol&#xD;
&#xD;
          -  Presence of depressive symptoms that could influence cognitive function&#xD;
&#xD;
          -  Presence of medical comorbidities that could result in cognitive decline Use of&#xD;
             medication that could influence cognitive function seriously&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ki Woong Kim, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital, Seong-nam, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Ki Woong Kim</investigator_full_name>
    <investigator_title>Professor, department of neuropsychiatry</investigator_title>
  </responsible_party>
  <keyword>Mild cognitive impairment</keyword>
  <keyword>Cognitive rehabilitation</keyword>
  <keyword>Cognitive therapy</keyword>
  <keyword>Spaced retrieval Training</keyword>
  <keyword>Alzheimer's disease</keyword>
  <keyword>Memory enhancement</keyword>
  <keyword>U-healthcare</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/NCT01688128
org study id: E-1207/162-001
nct id: NCT01688128
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based
      Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild
      cognitive impairment (MCI) by an open-label, controlled, crossover Trial.
The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which
      consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on
      the spaced retrieval training (SRT), which was effective in improving memory retention span
      of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by
      transforming the current SMART to a self-administered program using an application working on
      IPAD was developed, and showed its feasibility and efficacy in the elderly individuals with
      mild cognitive impairment in the preliminary study. (ClinicalTrials.gov ID: NCT01628653) To
      validate the efficacy of the U-SMART, an open-label, controlled, crossover design of clinical
      trial were planned in this study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Word List Test (memory, recall, recognition) of the CERAD Neuropsychological Assessment Battery before and after phase I intervention and before and after phase II intervention (crossover part of the study)
time frame: Baseline, 5 weeks, 11weeks
description: To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT), Word List Recall Test (WLRT), Word List Recognition Test (WLRcT) of the CERAD neuropsychological assessment battery were applied to all participants.
measure: Change in the Subjective Memory Complaints Questionnaire (SMCQ) before and after phase I intervention and before and after phase II intervention (crossover part of the study)
time frame: Baseline, 5 weeks, 11weeks
description: To evaluate the subjective memory improvement after the U-SMART, the Subjective Memory Complaints Questionnaire(SMCQ) was applied to all participants.
measure: Change in the Geriatric Depression Scale (GDS) before and after phase I intervention and before and after phase II intervention (crossover part of the study)
time frame: Baseline, 5 weeks, 11weeks
description: To evaluate the subjective mood after the U-SMART, the Geriatric Depression Scale was applied to all participants.
measure: Change in the Mini-Mental State Examination before and after phase I intervention and before and after phase II intervention (crossover part of the study)
time frame: Baseline, 5 weeks, 11weeks
description: To evaluate the global cognitive function after the U-SMART, the Mini-Mental State Examination was applied to all participants.
arm group label: Intervention_Control group
arm group type: Experimental
description: Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks
arm group label: Control_Intervention group
arm group type: Experimental
description: Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)
intervention type: Device
intervention name: Phase I U-SMART (4 wks)
description: Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention
arm group label: Intervention_Control group
intervention type: Other
intervention name: Washout (2 wks)
description: 2-weeks wash out period in both arms
arm group label: Control_Intervention group
arm group label: Intervention_Control group
intervention type: Device
intervention name: Phase II U-SMART (4 wks)
description: Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)
arm group label: Control_Intervention group
criteria: 
gender: All
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ki Woong Kim, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital, Seong-nam, Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Ki Woong Kim
investigator title: Professor, department of neuropsychiatry
mesh term: Cognitive Dysfunction