<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/NCT02205710</url>
  </required_header>
  <id_info>
    <org_study_id>M16-14-018</org_study_id>
    <nct_id>NCT02205710</nct_id>
  </id_info>
  <brief_title>Adaptive Cognitive Training in Healthy Older Adults</brief_title>
  <official_title>Adaptive Cognitive Training in Healthy Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bruyere Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bruyere Research Institute</source>
  <brief_summary>
    <textblock>
      Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate&#xD;
      cognitive function in older adults and individuals with dementia. In recent years, such&#xD;
      training has become particularly appealing in the clinical context, with many paradigms aimed&#xD;
      specifically at adults experiencing various stages of cognitive decline due to Mild Cognitive&#xD;
      Impairment, Alzheimer's disease, and vascular dementias. However, basic questions remain. For&#xD;
      example, uncertainty persists regarding factors that influence observed improvements as well&#xD;
      as the conditions that would maximize transfer and sustainability of training effects. The&#xD;
      objective of this study is to evaluate factors that may maximize the benefits of computerized&#xD;
      cognitive training in older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study involves 25 sessions of an adaptive cognitive training program, completed over 5&#xD;
      weeks. Pre and post training assessments will evaluate any near and far transfer effects of&#xD;
      training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ratings on cognitive training survey</measure>
    <time_frame>Baseline, week 5</time_frame>
    <description>This survey aims to assess participant perceptions on cognitive training, and includes a series of related questions, rated on a scale of 1-7.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in neural activity</measure>
    <time_frame>Baseline, week 5</time_frame>
    <description>We will measure resting state as well as task-related EEG responses to determine the effects of cognitive training at the neural level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in performance on neuropsychological tests</measure>
    <time_frame>Baseline, week 5</time_frame>
    <description>Using a set of standard neuropsychological evaluations, we will measure changes in attention, memory, and executive function following cognitive training.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ratings of psychological wellbeing</measure>
    <time_frame>Baseline, week 5</time_frame>
    <description>We will use standardized questionnaires to assess quality of life, in order to measure the influence of cognitive training on factors related to wellbeing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Mild to Moderate Dementia</condition>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Computerized cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Series of gamified tasks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computerized game training</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Series of gamified tasks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computerized cognitive training</intervention_name>
    <arm_group_label>Computerized cognitive training</arm_group_label>
    <other_name>Activate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computerized games</intervention_name>
    <arm_group_label>Computerized game training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English as the maternal or primary spoken language.&#xD;
&#xD;
          -  Good self-reported health (i.e., no cerebro-, or cardio-vascular disease or&#xD;
             neurological disease).&#xD;
&#xD;
          -  Normal or corrected-to-normal vision and hearing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor hearing or vision&#xD;
&#xD;
          -  Inadequate understanding of the English language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Davidson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sheida Rabipour, MSc</last_name>
    <role>Study Director</role>
    <affiliation>University of Ottawa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bruyere Continuing Care</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N 5C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <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/NCT02205710
org study id: M16-14-018
nct id: NCT02205710
lead sponsor: 
collaborator: 
Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate
      cognitive function in older adults and individuals with dementia. In recent years, such
      training has become particularly appealing in the clinical context, with many paradigms aimed
      specifically at adults experiencing various stages of cognitive decline due to Mild Cognitive
      Impairment, Alzheimer's disease, and vascular dementias. However, basic questions remain. For
      example, uncertainty persists regarding factors that influence observed improvements as well
      as the conditions that would maximize transfer and sustainability of training effects. The
      objective of this study is to evaluate factors that may maximize the benefits of computerized
      cognitive training in older adults.
The study involves 25 sessions of an adaptive cognitive training program, completed over 5
      weeks. Pre and post training assessments will evaluate any near and far transfer effects of
      training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in ratings on cognitive training survey
time frame: Baseline, week 5
description: This survey aims to assess participant perceptions on cognitive training, and includes a series of related questions, rated on a scale of 1-7.
measure: Change in neural activity
time frame: Baseline, week 5
description: We will measure resting state as well as task-related EEG responses to determine the effects of cognitive training at the neural level.
measure: Change in performance on neuropsychological tests
time frame: Baseline, week 5
description: Using a set of standard neuropsychological evaluations, we will measure changes in attention, memory, and executive function following cognitive training.
measure: Change in ratings of psychological wellbeing
time frame: Baseline, week 5
description: We will use standardized questionnaires to assess quality of life, in order to measure the influence of cognitive training on factors related to wellbeing.
arm group label: Computerized cognitive training
arm group type: Experimental
description: Series of gamified tasks.
arm group label: Computerized game training
arm group type: Placebo Comparator
description: Series of gamified tasks.
intervention type: Other
intervention name: Computerized cognitive training
arm group label: Computerized cognitive training
other name: Activate
intervention type: Other
intervention name: Computerized games
arm group label: Computerized game training
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick Davidson, PhD
role: Principal Investigator
affiliation: University of Ottawa
last name: Sheida Rabipour, MSc
role: Study Director
affiliation: University of Ottawa
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction