<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/NCT03786510</url>
  </required_header>
  <id_info>
    <org_study_id>MDP_AD</org_study_id>
    <nct_id>NCT03786510</nct_id>
  </id_info>
  <brief_title>A Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia</brief_title>
  <official_title>A Pilot Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul Metropolitan Government</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</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>
      Investigators aimed to examine the feasibility and effectiveness of a multidomain&#xD;
      intervention strategy involving intensive and maintenance programs aimed at reducing the risk&#xD;
      of Alzheimer's disease (AD) in at-risk older adults. Participants were randomly allocated&#xD;
      into three groups: (1) intensive plus maintenance program (INT+MNT group), (2) intensive&#xD;
      program only (INT-only group), and (3) active control (control group). There were two study&#xD;
      hypotheses: 1) the participants in the 4-week intensive program (INT+MNT and INT-only group)&#xD;
      would show reduced dementia risk scores compared to control; and 2) that the participants in&#xD;
      the added 20-week maintenance program (INT+MNT group) would show greater improvement in&#xD;
      dementia risk scores compared to the INT-only and control groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES: To examine the feasibility and effectiveness of a multidomain intervention&#xD;
      strategy involving intensive and maintenance programs aimed at reducing the risk of&#xD;
      Alzheimer's disease (AD) in at-risk older adults.&#xD;
&#xD;
      DESIGN: A prospective randomized controlled trial with participants assigned to three&#xD;
      parallel programs: intensive plus maintenance (INT+MNT), intensive only (INT-only), and&#xD;
      active control.&#xD;
&#xD;
      SETTING: A community center for dementia in South Korea.&#xD;
&#xD;
      PARTICIPANTS: Community-dwelling older adults (aged ≥ 60 years) without dementia, but having&#xD;
      several risk factors for AD.&#xD;
&#xD;
      MEASUREMENTS: The study subjects participated in a 4-week intensive group-based lifestyle&#xD;
      modification program that focused on physical activity, vascular risk factors, dietary&#xD;
      habits, cognitive activities, and social engagement. Then, the participants underwent a&#xD;
      20-week maintenance program to consolidate modified habits. Linear mixed models were used to&#xD;
      examine the changes in modified Australian National University-Alzheimer's Disease Risk Index&#xD;
      (ANU-ADRI) scores in each group. Additional analyses of secondary outcomes, including&#xD;
      cognitive function, were also performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</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>A single-blinded randomized controlled pilot study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline Australian National University Alzheimer's Disease Index (ANU-ADRI) at 4 weeks and 24 week</measure>
    <time_frame>baseline (0 week), 4-week, 24-week</time_frame>
    <description>The ANU-ADRI was developed based on review and meta-analysis of the literature regarding modifiable risk and protective factors for AD; it is a validated instrument assessing individual risk profiles for AD that combines the odds ratios of risk factors to derive a risk score. The total scores ranged from -18 to 63 for males, and from -18 to 66 for females; higher scores indicated greater risk for AD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Short Physical Performance Battery (SPPB) at 4 weeks and 24 week</measure>
    <time_frame>baseline (0 week), 4-week, 24-week</time_frame>
    <description>The SPPB was developed for evaluating lower extremity functioning in older persons. The scores range from 0 to 12; higher scores indicated better performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline total score in the CERAD neuropsychological battery at 4 weeks and 24 week</measure>
    <time_frame>baseline (0 week), 4-week, 24-week</time_frame>
    <description>The CERAD neuropsychological battery includes various cognitive domains: memory, language, visuospatial, executive, etc. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Color Word Stroop Test (CWST) at 4 weeks and 24 week</measure>
    <time_frame>baseline (0 week), 4-week, 24-week</time_frame>
    <description>CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) at 4 weeks and 24 week</measure>
    <time_frame>baseline (0 week), 4-week, 24-week</time_frame>
    <description>The S-IADL includes 15 items in regard with various instrumental activities of daily living. The total scores ranged from 0 to 15; higher scores indicated lower level of daily function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline EuroQol Five-Dimensional Questionnaire (EQ-5D) at 4 weeks and 24 week</measure>
    <time_frame>baseline (0 week), 4-week, 24-week</time_frame>
    <description>The EQ-5D is consisted of five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The total scores ranged from 5 to 15; higher scores indicated lower quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction Scale (MCLHB-DRR) scale at 4 weeks and 24 week</measure>
    <time_frame>baseline (0 week), 4-week, 24-week</time_frame>
    <description>The MCLHB-DRR was developed to understand beliefs underpinning the lifestyle and health behavioural changes needed for dementia risk reduction. Seven-factor solution (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, general health motivation, self-efficiency) with 27 items were included. The total scores ranged from 0 to 27; higher scores indicate higher motivation for reducing risk of dementia</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Active control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group received Community Center for Dementia's usual care of regular health check-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive + Maintenance program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The INT+MNT group participated in a 4-week intensive program followed by a 20-week maintenance program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive program only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The INT only group participated in a 4-week intensive program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active control</intervention_name>
    <description>Control group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia.</description>
    <arm_group_label>Active control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive + Maintenance program</intervention_name>
    <description>Both intensive and maintenance program&#xD;
Intensive program The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.&#xD;
Maintenance program The allocated study assistants monthly check-up whether participants adhere to the altered habits or not, based on the workbook</description>
    <arm_group_label>Intensive + Maintenance program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive program only</intervention_name>
    <description>Only the intensive program was conducted.&#xD;
The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.</description>
    <arm_group_label>Intensive program only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 60 years and over with age-, sex-, education-adjusted z-score of the&#xD;
             Korean version of mini-mental state examination for dementia screening (MMSE-DS) -1.5&#xD;
             standard deviation and above, but having some risk factors for dementia were included:&#xD;
             at least two of following risk factors in a recent year (1) do not exercise with&#xD;
             moderate degree more than 3 times a week, (2) do not read books, newspapers or&#xD;
             magazine more than once a week; (3) do not meet friends, relatives, or close person&#xD;
             more than once a week, (4) have depressed mood or low volition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were previously diagnosed with dementia or other neurologic&#xD;
             disorders (e.g., Parkinson's disease); stroke in a recent year or having significant&#xD;
             sequelae of past stroke; major psychiatric disorders (e.g., major depressive disorder)&#xD;
             in a recent year; having absolute contraindication to participate in exercise program&#xD;
             (e.g., need a wheelchair for mobility). Also, subjects who were already participated&#xD;
             in other exercise or cognitive stimulating program in the Community Center for&#xD;
             Dementia were excluded in the present study.&#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>
  <location>
    <facility>
      <name>Seoul National University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 23, 2018</last_update_submitted>
  <last_update_submitted_qc>December 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Risk reduction</keyword>
  <keyword>Community</keyword>
  <keyword>Older adults</keyword>
  <keyword>Lifestyle modification</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03786510
org study id: MDP_AD
nct id: NCT03786510
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators aimed to examine the feasibility and effectiveness of a multidomain
      intervention strategy involving intensive and maintenance programs aimed at reducing the risk
      of Alzheimer's disease (AD) in at-risk older adults. Participants were randomly allocated
      into three groups: (1) intensive plus maintenance program (INT+MNT group), (2) intensive
      program only (INT-only group), and (3) active control (control group). There were two study
      hypotheses: 1) the participants in the 4-week intensive program (INT+MNT and INT-only group)
      would show reduced dementia risk scores compared to control; and 2) that the participants in
      the added 20-week maintenance program (INT+MNT group) would show greater improvement in
      dementia risk scores compared to the INT-only and control groups.
OBJECTIVES: To examine the feasibility and effectiveness of a multidomain intervention
      strategy involving intensive and maintenance programs aimed at reducing the risk of
      Alzheimer's disease (AD) in at-risk older adults.

      DESIGN: A prospective randomized controlled trial with participants assigned to three
      parallel programs: intensive plus maintenance (INT+MNT), intensive only (INT-only), and
      active control.

      SETTING: A community center for dementia in South Korea.

      PARTICIPANTS: Community-dwelling older adults (aged ≥ 60 years) without dementia, but having
      several risk factors for AD.

      MEASUREMENTS: The study subjects participated in a 4-week intensive group-based lifestyle
      modification program that focused on physical activity, vascular risk factors, dietary
      habits, cognitive activities, and social engagement. Then, the participants underwent a
      20-week maintenance program to consolidate modified habits. Linear mixed models were used to
      examine the changes in modified Australian National University-Alzheimer's Disease Risk Index
      (ANU-ADRI) scores in each group. Additional analyses of secondary outcomes, including
      cognitive function, were also performed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A single-blinded randomized controlled pilot study
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Changes from baseline Australian National University Alzheimer's Disease Index (ANU-ADRI) at 4 weeks and 24 week
time frame: baseline (0 week), 4-week, 24-week
description: The ANU-ADRI was developed based on review and meta-analysis of the literature regarding modifiable risk and protective factors for AD; it is a validated instrument assessing individual risk profiles for AD that combines the odds ratios of risk factors to derive a risk score. The total scores ranged from -18 to 63 for males, and from -18 to 66 for females; higher scores indicated greater risk for AD.
measure: Changes from baseline Short Physical Performance Battery (SPPB) at 4 weeks and 24 week
time frame: baseline (0 week), 4-week, 24-week
description: The SPPB was developed for evaluating lower extremity functioning in older persons. The scores range from 0 to 12; higher scores indicated better performance.
measure: Changes from baseline total score in the CERAD neuropsychological battery at 4 weeks and 24 week
time frame: baseline (0 week), 4-week, 24-week
description: The CERAD neuropsychological battery includes various cognitive domains: memory, language, visuospatial, executive, etc. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.
measure: Changes from baseline Color Word Stroop Test (CWST) at 4 weeks and 24 week
time frame: baseline (0 week), 4-week, 24-week
description: CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.
measure: Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) at 4 weeks and 24 week
time frame: baseline (0 week), 4-week, 24-week
description: The S-IADL includes 15 items in regard with various instrumental activities of daily living. The total scores ranged from 0 to 15; higher scores indicated lower level of daily function.
measure: Changes from baseline EuroQol Five-Dimensional Questionnaire (EQ-5D) at 4 weeks and 24 week
time frame: baseline (0 week), 4-week, 24-week
description: The EQ-5D is consisted of five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The total scores ranged from 5 to 15; higher scores indicated lower quality of life.
measure: Changes from baseline Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction Scale (MCLHB-DRR) scale at 4 weeks and 24 week
time frame: baseline (0 week), 4-week, 24-week
description: The MCLHB-DRR was developed to understand beliefs underpinning the lifestyle and health behavioural changes needed for dementia risk reduction. Seven-factor solution (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, general health motivation, self-efficiency) with 27 items were included. The total scores ranged from 0 to 27; higher scores indicate higher motivation for reducing risk of dementia
arm group label: Active control
arm group type: Active Comparator
description: The control group received Community Center for Dementia's usual care of regular health check-up.
arm group label: Intensive + Maintenance program
arm group type: Experimental
description: The INT+MNT group participated in a 4-week intensive program followed by a 20-week maintenance program
arm group label: Intensive program only
arm group type: Experimental
description: The INT only group participated in a 4-week intensive program
intervention type: Behavioral
intervention name: Active control
description: Control group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia.
arm group label: Active control
intervention type: Behavioral
intervention name: Intensive + Maintenance program
description: Both intensive and maintenance program
Intensive program The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.
Maintenance program The allocated study assistants monthly check-up whether participants adhere to the altered habits or not, based on the workbook
arm group label: Intensive + Maintenance program
intervention type: Behavioral
intervention name: Intensive program only
description: Only the intensive program was conducted.
The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.
arm group label: Intensive program only
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
sharing ipd: Undecided