<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/NCT04452864</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00630</org_study_id>
    <nct_id>NCT04452864</nct_id>
  </id_info>
  <brief_title>Tablet-based Cognitive Training</brief_title>
  <official_title>Can a Serious Game-based Cognitive Training Attenuate Cognitive Decline Related to Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bern</source>
  <oversight_info>
    <has_dmc>No</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>
      Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One&#xD;
      recommended intervention is cognitive stimulation. We try to develop serious games as a&#xD;
      further treatment option, also usable in pre-dementia as well as early stages of dementia and&#xD;
      for a long period of time.&#xD;
&#xD;
      The main objective of this study is to test, if the computerized-cognitive training (CCT) is&#xD;
      able to improve the performance in a score quantifying an &quot;AD-specific&quot; component score.&#xD;
      Additionally, the neurobiological effects of the training are investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study intervention consists of a computer-based cognitive training, targeting the&#xD;
      cognitive domains mostly affected by AD. This training will be performed for three months&#xD;
      (each day for 20 minutes). After three months the intervention group will continue the&#xD;
      training at home for six months and meet monthly for group sessions (i.e. booster sessions)&#xD;
      on site.&#xD;
&#xD;
      Primary endpoint will be the change in an &quot;AD-specific&quot; component score, quantified by&#xD;
      episodic memory, semantic memory and visuospatial abilities. Secondary endpoints are changes&#xD;
      in task related brain networks and changes in resting state networks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2024</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>
    <intervention_model_description>Participants will be randomly assigned to one of three study arms and conduct a Computerized Cognitive Training (CCT) at home (daily) and on site (weekly) for 10 weeks. Before and after the CCT, neuropsychological assessments will be conducted.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in AD specific component score</measure>
    <time_frame>The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months.</time_frame>
    <description>The outcome is quantified by an AD component score including measures of EM (auditory verbal learning), SM (verbal fluency, naming task) and spatial abilities (Rey-Osterrieth complex figure test). These scores will be assessed four times, before the training as well as after three, six and nine months by tablet-based cognitive tests. A short follow-up assessment will be performed after a total of 12 months which does not include primary outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MRI functional and structural</measure>
    <time_frame>Secondary endpoints will be assessed two to four times, depending on the study arm, as MRI assessments are not always performed after six and nine months.</time_frame>
    <description>Secondary endpoints are changes in task related brain networks (i.e. spatial ability and episodic memory) and changes in resting state networks.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">162</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Dementia</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Study Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months this group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This control study arm will watch documentaries at home for three months (each day for 20 minutes) , instead of performing the CCT and serve as active control group. This group will also train with the CCT tasks after these three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This control study arm will start with the CCT with a delay of three months and serve as wait-list control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computerized Cognitive Training</intervention_name>
    <description>The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.</description>
    <arm_group_label>Study Intervention</arm_group_label>
    <arm_group_label>Wait-List Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Documentaries with delayed Computerized Cognitive Training</intervention_name>
    <description>The active control group watches documentaries for three months before starting with the CCT.</description>
    <arm_group_label>Active Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Alzheimer's Disease&#xD;
&#xD;
          -  Patients with increased risk for developing dementia&#xD;
&#xD;
          -  Must be able to give their consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra-indications for MRI scanning&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Severe medical conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Klöppel, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Esther Brill, M.Sc.</last_name>
    <phone>+41 31 930 9634</phone>
    <email>esther.brill@upd.unibe.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christine Krebs, M.Sc.</last_name>
    <email>christine.krebs@upd.unibe.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of Old Age Psychiatry and Psychotherapy</name>
      <address>
        <city>Bern</city>
        <zip>3000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Esther Brill, M.Sc.</last_name>
      <phone>+41 31 930 9634</phone>
      <email>esther.brill@upd.unibe.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memory Clinic Zentralschweiz</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna-Katharine Brem, Dr.</last_name>
      <phone>+41 58 856 61 72</phone>
      <email>anna.brem@lups.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer Disease</keyword>
  <keyword>Dementia</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <keyword>Cognitive Training</keyword>
  <keyword>Serious Games</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication will be published pseudonymized in a open access data base</ipd_description>
    <ipd_time_frame>IPD and any additional material will be available when data collection and analysis is completed Items will be retained for the lifetime of the repository (at least 20years)</ipd_time_frame>
    <ipd_access_criteria>According to SNF Guidelines IPD will be published in a open access data base</ipd_access_criteria>
  </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/NCT04452864
org study id: 2020-00630
nct id: NCT04452864
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One
      recommended intervention is cognitive stimulation. We try to develop serious games as a
      further treatment option, also usable in pre-dementia as well as early stages of dementia and
      for a long period of time.

      The main objective of this study is to test, if the computerized-cognitive training (CCT) is
      able to improve the performance in a score quantifying an "AD-specific" component score.
      Additionally, the neurobiological effects of the training are investigated.
The study intervention consists of a computer-based cognitive training, targeting the
      cognitive domains mostly affected by AD. This training will be performed for three months
      (each day for 20 minutes). After three months the intervention group will continue the
      training at home for six months and meet monthly for group sessions (i.e. booster sessions)
      on site.

      Primary endpoint will be the change in an "AD-specific" component score, quantified by
      episodic memory, semantic memory and visuospatial abilities. Secondary endpoints are changes
      in task related brain networks and changes in resting state networks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to one of three study arms and conduct a Computerized Cognitive Training (CCT) at home (daily) and on site (weekly) for 10 weeks. Before and after the CCT, neuropsychological assessments will be conducted.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in AD specific component score
time frame: The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months.
description: The outcome is quantified by an AD component score including measures of EM (auditory verbal learning), SM (verbal fluency, naming task) and spatial abilities (Rey-Osterrieth complex figure test). These scores will be assessed four times, before the training as well as after three, six and nine months by tablet-based cognitive tests. A short follow-up assessment will be performed after a total of 12 months which does not include primary outcome measure.
measure: MRI functional and structural
time frame: Secondary endpoints will be assessed two to four times, depending on the study arm, as MRI assessments are not always performed after six and nine months.
description: Secondary endpoints are changes in task related brain networks (i.e. spatial ability and episodic memory) and changes in resting state networks.
arm group label: Study Intervention
arm group type: Experimental
description: The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months this group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site.
arm group label: Active Control Group
arm group type: Active Comparator
description: This control study arm will watch documentaries at home for three months (each day for 20 minutes) , instead of performing the CCT and serve as active control group. This group will also train with the CCT tasks after these three months.
arm group label: Wait-List Control
arm group type: Other
description: This control study arm will start with the CCT with a delay of three months and serve as wait-list control group.
intervention type: Device
intervention name: Computerized Cognitive Training
description: The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.
arm group label: Study Intervention
arm group label: Wait-List Control
intervention type: Device
intervention name: Documentaries with delayed Computerized Cognitive Training
description: The active control group watches documentaries for three months before starting with the CCT.
arm group label: Active Control Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan Klöppel, Prof. Dr.
role: Principal Investigator
affiliation: University of Bern
last name: Esther Brill, M.Sc.
phone: +41 31 930 9634
email: esther.brill@upd.unibe.ch
last name: Christine Krebs, M.Sc.
email: christine.krebs@upd.unibe.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication will be published pseudonymized in a open access data base
ipd time frame: IPD and any additional material will be available when data collection and analysis is completed Items will be retained for the lifetime of the repository (at least 20years)
ipd access criteria: According to SNF Guidelines IPD will be published in a open access data base