<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/NCT02262975</url>
  </required_header>
  <id_info>
    <org_study_id>ART-M082-602</org_study_id>
    <nct_id>NCT02262975</nct_id>
  </id_info>
  <brief_title>A Multi-national Study to Identify Treatment Discontinuation Rate in de Novo Alzheimer's Disease Patients Who Have Been Newly Prescribed With Donepezil (Aricept) in Asia (ADOS)</brief_title>
  <acronym>ADOS</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Korea Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <brief_summary>
    <textblock>
      This study is an observational study conducted prospectively under routine clinical setting&#xD;
      for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by&#xD;
      donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected&#xD;
      institutions of about 8 countries in Asia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participation in this study places no additional visit schedule, which will be determined by&#xD;
      the investigator's judgment based on the disease progression of each subject. Investigators&#xD;
      educate subjects to keep decided visit schedule, and collect the required information for&#xD;
      case record from (CRF) on the visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment discontinuation Rate</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors leading to donepezil treatment discontinuation</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Reason for the subjects who discontinued the administration of donepezil (Aricept)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in treatment duration</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in treatment regimen</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in the scores of cognitive assessments test</measure>
    <time_frame>Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance of donepezil: Clinical Rating Scale (CRS)</measure>
    <time_frame>Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]</time_frame>
    <description>CRS is a compliance scale ranged from 1 to 7. The higher score implies the higher compliance. 5 points or higher is defined as compliance, while 4 points or lower as non-compliance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance of donepezil: Visual Analog Scale (VAS)</measure>
    <time_frame>Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]</time_frame>
    <description>VAS is a tool to determine the compliance through interview between investigators and subjects based on drug administration during previous 4 weeks. The range is from 0 to 100.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">532</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>donepezil (Aricept)</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Alzheimer's disease patients who have been recently prescribed with donepezil (Aricept) as&#xD;
        monotherapy for the first time&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Greater than or equal to 50 years old and less than 90 years old&#xD;
&#xD;
          2. Diagnosed as probable AD based on NINCDS-ADRDA&#xD;
&#xD;
          3. Patients who have been recently prescribed with donepezil (Aricept) as monotherapy&#xD;
&#xD;
          4. Patients and caregivers who signed the written informed consent from for use of&#xD;
             personal and medical information&#xD;
&#xD;
          5. Patients with caregivers who can visit the institution together&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Patients who have taken Memantine or Acetylcholinesterase (AChE) inhibitor prior to&#xD;
        participating in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gangwon</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shaanxi</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gyeonggi</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jeonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kangwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bangkok</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Changhua</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Korea, Republic of</country>
    <country>Philippines</country>
    <country>Singapore</country>
    <country>Taiwan</country>
    <country>Thailand</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's disease</keyword>
  <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/NCT02262975
org study id: ART-M082-602
nct id: NCT02262975
lead sponsor: 
This study is an observational study conducted prospectively under routine clinical setting
      for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by
      donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected
      institutions of about 8 countries in Asia.
Participation in this study places no additional visit schedule, which will be determined by
      the investigator's judgment based on the disease progression of each subject. Investigators
      educate subjects to keep decided visit schedule, and collect the required information for
      case record from (CRF) on the visit.
observational model: Case-Only
time perspective: Prospective
measure: Treatment discontinuation Rate
time frame: Up to 1 year
measure: Factors leading to donepezil treatment discontinuation
time frame: Up to 1 year
description: Reason for the subjects who discontinued the administration of donepezil (Aricept)
measure: Mean change in treatment duration
time frame: Up to 1 year
measure: Percent change in treatment regimen
time frame: Up to 1 year
measure: Mean change in the scores of cognitive assessments test
time frame: Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]
measure: Compliance of donepezil: Clinical Rating Scale (CRS)
time frame: Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]
description: CRS is a compliance scale ranged from 1 to 7. The higher score implies the higher compliance. 5 points or higher is defined as compliance, while 4 points or lower as non-compliance.
measure: Compliance of donepezil: Visual Analog Scale (VAS)
time frame: Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]
description: VAS is a tool to determine the compliance through interview between investigators and subjects based on drug administration during previous 4 weeks. The range is from 0 to 100.
arm group label: donepezil (Aricept)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 89 Years
healthy volunteers: No
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country: China
country: Korea, Republic of
country: Philippines
country: Singapore
country: Taiwan
country: Thailand
responsible party type: Sponsor
mesh term: Alzheimer Disease