<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/NCT02247180</url>
  </required_header>
  <id_info>
    <org_study_id>A 2014-0113</org_study_id>
    <nct_id>NCT02247180</nct_id>
  </id_info>
  <brief_title>Cognitive Rehabilitation in Alzheimer's Disease</brief_title>
  <official_title>Cognitive Rehabilitation in Alzheimer's Disease (AD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rostock</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Center for Neurodegenerative Diseases (DZNE)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rostock</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to proof the efficacy of a cognitive rehabilitation program for patients with&#xD;
      mild dementia in Alzheimers Disease with respect to activities of daily living.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized, single blind intervention study aims to proof a cognitive&#xD;
      rehabilitation program for patients with mild dementia in Alzheimers Disease (AD). The&#xD;
      investigators modified a manualized and established German behavioural therapy program&#xD;
      (KORDIAL) to use in a group context. The respective modules contain multimodal and&#xD;
      multiprofessional approaches to improve capabilities relevant to activities of daily living&#xD;
      (external memory support, compensation strategies, training of everyday competence,&#xD;
      communication training). The intervention group receives this therapy for 12 weeks. Age and&#xD;
      gender matched participants with AD serve as active control sample receiving a standardized&#xD;
      cognitive training in the domesticity. The primary outcome are measurements of skills in&#xD;
      activities of daily living prior the intervention as well as at the end of the intervention&#xD;
      (after 3 months) and after 6 months (Follow up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in activities of daily living measured by a test for action regulation and planning skills (HOTAP) to the end of intervention and to follow-up (6 months later)</measure>
    <time_frame>prior intervention, after intervention (3 months), after 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in activities of daily living measured by an ADL-scale (Bayer-ADL) to the end of intervention and to follow-up (6 months later)</measure>
    <time_frame>prior intervention, after intervention (3 months), after 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in behavioural memory abilities measured by a behavioural memory test (RBMT) to the end of intervention and to follow-up (6 months later)</measure>
    <time_frame>prior intervention, after intervention (3 months), after 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in general cognitive state measured by the Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) to the end of intervention and to follow-up (6 months later)</measure>
    <time_frame>prior intervention, after intervention (3 months), after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in structural and functional connectivity of the brain measured by MRI to the end of intervention and to follow-up (6 months later)</measure>
    <time_frame>prior intervention, after intervention (3 months), after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in depression and quality of life measured by two scales (GDS, DEMQoL) to the end of intervention and to follow-up (6 months later)</measure>
    <time_frame>prior intervention, after intervention (3 months), after 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Cognitive Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cognitive rehabilitation for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standardized cognitive training in the domesticity</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive rehabilitation</intervention_name>
    <arm_group_label>Cognitive Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>standardized cognitive training</intervention_name>
    <arm_group_label>Cognitive Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild dementia in Alzheimer's disease (NINCDS-ADRDA)&#xD;
&#xD;
          -  Mini Mental State ≥ 17&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe psychiatric disorder&#xD;
&#xD;
          -  severe brain disorder (epilepsy, tumor, stroke)&#xD;
&#xD;
          -  contraindication for MRI examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Teipel, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elisabeth Kasper</last_name>
    <phone>+49 0381 4949618</phone>
    <email>elisabeth.kasper@med.uni-rostock.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yvonne Schmidt</last_name>
    <phone>+49 0381 4949471</phone>
    <email>yvonne.schmidt@dzne.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Psychosomatic Medicine, University of Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabeth Kasper</last_name>
      <phone>+49 381 4949618</phone>
      <email>elisabeth.kasper@med.uni-rostock.de</email>
    </contact>
    <investigator>
      <last_name>Elisabeth Kasper</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rostock</investigator_affiliation>
    <investigator_full_name>Elisabeth Kasper</investigator_full_name>
    <investigator_title>Dipl. psych</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT02247180
org study id: A 2014-0113
nct id: NCT02247180
lead sponsor: 
collaborator: 
has dmc: No
This study aims to proof the efficacy of a cognitive rehabilitation program for patients with
      mild dementia in Alzheimers Disease with respect to activities of daily living.
This prospective randomized, single blind intervention study aims to proof a cognitive
      rehabilitation program for patients with mild dementia in Alzheimers Disease (AD). The
      investigators modified a manualized and established German behavioural therapy program
      (KORDIAL) to use in a group context. The respective modules contain multimodal and
      multiprofessional approaches to improve capabilities relevant to activities of daily living
      (external memory support, compensation strategies, training of everyday competence,
      communication training). The intervention group receives this therapy for 12 weeks. Age and
      gender matched participants with AD serve as active control sample receiving a standardized
      cognitive training in the domesticity. The primary outcome are measurements of skills in
      activities of daily living prior the intervention as well as at the end of the intervention
      (after 3 months) and after 6 months (Follow up).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in activities of daily living measured by a test for action regulation and planning skills (HOTAP) to the end of intervention and to follow-up (6 months later)
time frame: prior intervention, after intervention (3 months), after 6 months
measure: Change from baseline in activities of daily living measured by an ADL-scale (Bayer-ADL) to the end of intervention and to follow-up (6 months later)
time frame: prior intervention, after intervention (3 months), after 6 months
measure: Change from baseline in behavioural memory abilities measured by a behavioural memory test (RBMT) to the end of intervention and to follow-up (6 months later)
time frame: prior intervention, after intervention (3 months), after 6 months
measure: Change from baseline in general cognitive state measured by the Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) to the end of intervention and to follow-up (6 months later)
time frame: prior intervention, after intervention (3 months), after 6 months
measure: Change from baseline in structural and functional connectivity of the brain measured by MRI to the end of intervention and to follow-up (6 months later)
time frame: prior intervention, after intervention (3 months), after 6 months
measure: Change from baseline in depression and quality of life measured by two scales (GDS, DEMQoL) to the end of intervention and to follow-up (6 months later)
time frame: prior intervention, after intervention (3 months), after 6 months
arm group label: Cognitive Rehabilitation
arm group type: Experimental
description: cognitive rehabilitation for 12 weeks
arm group label: Cognitive Training
arm group type: Active Comparator
description: standardized cognitive training in the domesticity
intervention type: Behavioral
intervention name: cognitive rehabilitation
arm group label: Cognitive Rehabilitation
intervention type: Behavioral
intervention name: standardized cognitive training
arm group label: Cognitive Training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Stefan Teipel, Prof.
role: Principal Investigator
affiliation: Department of Psychosomatic Medicine, University of Rostock, Rostock, Germany
last name: Elisabeth Kasper
phone: +49 0381 4949618
email: elisabeth.kasper@med.uni-rostock.de
last name: Yvonne Schmidt
phone: +49 0381 4949471
email: yvonne.schmidt@dzne.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Rostock
investigator full name: Elisabeth Kasper
investigator title: Dipl. psych
mesh term: Alzheimer Disease