<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/NCT01734395</url>
  </required_header>
  <id_info>
    <org_study_id>CR100958</org_study_id>
    <secondary_id>GAL-KOR-024</secondary_id>
    <secondary_id>GALALZ4045</secondary_id>
    <nct_id>NCT01734395</nct_id>
  </id_info>
  <brief_title>A Study to Show That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease</brief_title>
  <official_title>An Observational, Multi-Center Study to Demonstrate That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Korea, Ltd., Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Korea, Ltd., Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate that the change of attention measure is&#xD;
      correlated with the changes of caregiver's burden after treatment with galantamine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), prospective (in&#xD;
      which the participants are first identified and then followed forward as time passes),&#xD;
      observational (study in which the investigators/ physicians observe the patients and measure&#xD;
      their outcomes), multi-center (study conducted at multiple sites) study. The study mainly&#xD;
      consists of 2 phases including, the screening phase (14 days before administration of study&#xD;
      medication) and treatment phase (16 weeks). In the treatment phase, patients will receive&#xD;
      galantamine 8 mg/day for the first 4 weeks and later on the dose will be increased up to 24mg&#xD;
      (if tolerable). Safety evaluations will include assessment of adverse events. The total&#xD;
      duration of the study will be 18 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2007</start_date>
  <completion_date type="Actual">January 2008</completion_date>
  <primary_completion_date type="Actual">January 2008</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>Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)</measure>
    <time_frame>Baseline (Week 1 [Day 1]), Week 16</time_frame>
    <description>AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline at Week 16 in Burden Interview (BI) Scores</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1882</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Galantamine</arm_group_label>
    <description>Patients will receive galantamine 8 mg/day for the first 4 weeks and the dose of galantamine will be increased up to 24 mg (if tolerable).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Galantamine</intervention_name>
    <description>This is an observational study. Galantamine 8 mg/day will be administered for the first 4 weeks and later on the dose will increased up to 24 mg (if tolerable). Galantamine dose will be adjusted according to the investigator's discretion.</description>
    <arm_group_label>Galantamine</arm_group_label>
    <other_name>Razadyne</other_name>
    <other_name>Reminyl</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Alzheimer's disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alzheimer's disease according to the criteria of Diagnostic and Statistical Manual of&#xD;
             Mental Disorders, Fourth Edition (DSM-IV), National Institute of Neurological and&#xD;
             Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders&#xD;
             Association (NINCDS-ADRDA)&#xD;
&#xD;
          -  Measuring standard: K-MMSE is 10 to 24&#xD;
&#xD;
          -  Patient with reliable Guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with brain tumor, nerve syphilis, meningitis, encephalitis, epilepsy&#xD;
&#xD;
          -  Major psychiatric patients such as major depression and schizophrenia&#xD;
&#xD;
          -  Patients with treatment-resistant gastric and peptic ulcer&#xD;
&#xD;
          -  Patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease&#xD;
             (thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Korea, Ltd., Korea Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Korea, Ltd., Korea</affiliation>
  </overall_official>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>April 15, 2013</results_first_submitted>
  <results_first_submitted_qc>August 2, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 5, 2013</results_first_posted>
  <last_update_submitted>August 2, 2013</last_update_submitted>
  <last_update_submitted_qc>August 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's disease</keyword>
  <keyword>Caregiver's Burden in Alzheimer's disease</keyword>
  <keyword>Galantamine</keyword>
  <keyword>Razadyne</keyword>
  <keyword>Reminyl</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Caregiver Burden</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Galantamine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>1,882 participants were recruited to the 84 study centers.</recruitment_details>
      <pre_assignment_details>Out of 1,882 participants, 489 participants violated the inclusion/exclusion criteria and were excluded from the full analysis set (FAS). 1,472 participants completed the study. Total 1,393 participants were included in the FAS population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Galantamine</title>
          <description>Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1882"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1472"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="410"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="287"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing the reasons for not completed</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were determined in Full Analysis Set (FAS) population. Out of 1,882 enrolled participants, 1,393 participants were included in the FAS and 489 participants were excluded due to violation of the inclusion/exclusion criteria.</population>
      <group_list>
        <group group_id="B1">
          <title>Galantamine</title>
          <description>Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1393"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.11" spread="8.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="895"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Severity of symptoms of dementia</title>
          <description>Dementia is a general term for a decline in mental ability severe enough to interfere with daily life. Some of the most common form of dementia is Alzheimer's disease. The severity of dementia is divided as: (1) Suspected dementia (it is also named as Pre-dementia - often mistakenly attributed to ageing or stress), (2) Mild dementia, (3) Moderate dementia, (4) Sever dementia, and (5) Late (very severe) dementia.</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Suspected dementia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate dementia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe dementia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Late (very severe) dementia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild dementia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)</title>
        <description>AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.</description>
        <time_frame>Baseline (Week 1 [Day 1]), Week 16</time_frame>
        <population>FAS (Full Analysis Set) was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Galantamine</title>
            <description>Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)</title>
          <description>AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.</description>
          <population>FAS (Full Analysis Set) was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1393"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.19" spread="4.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.19</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>4.56</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4262</ci_lower_limit>
            <ci_upper_limit>-0.9467</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline at Week 16 in Burden Interview (BI) Scores</title>
        <description>BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Galantamine</title>
            <description>Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline at Week 16 in Burden Interview (BI) Scores</title>
          <description>BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.</description>
          <population>FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1393"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.48" spread="10.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.48</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>10.69</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9188</ci_lower_limit>
            <ci_upper_limit>2.0438</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)</title>
        <description>MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria</population>
        <group_list>
          <group group_id="O1">
            <title>Galantamine</title>
            <description>Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)</title>
          <description>MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.</description>
          <population>FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1393"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="2.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.69</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.43</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.814</ci_lower_limit>
            <ci_upper_limit>-0.5586</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 16 weeks</time_frame>
      <desc>Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Galantamine</title>
          <description>Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="1882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1882"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1882"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1882"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1882"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1882"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Research Director</name_or_title>
      <organization>Jan-Cil Korea</organization>
      <phone>82 2 2094 ext 4518</phone>
    </point_of_contact>
  </clinical_results>
</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/NCT01734395
org study id: CR100958
secondary id: GAL-KOR-024
secondary id: GALALZ4045
nct id: NCT01734395
lead sponsor: 
has dmc: No
The purpose of this study is to demonstrate that the change of attention measure is
      correlated with the changes of caregiver's burden after treatment with galantamine.
This is an open-label (all people know the identity of the intervention), prospective (in
      which the participants are first identified and then followed forward as time passes),
      observational (study in which the investigators/ physicians observe the patients and measure
      their outcomes), multi-center (study conducted at multiple sites) study. The study mainly
      consists of 2 phases including, the screening phase (14 days before administration of study
      medication) and treatment phase (16 weeks). In the treatment phase, patients will receive
      galantamine 8 mg/day for the first 4 weeks and later on the dose will be increased up to 24mg
      (if tolerable). Safety evaluations will include assessment of adverse events. The total
      duration of the study will be 18 weeks.
observational model: Case-Only
time perspective: Prospective
measure: Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)
time frame: Baseline (Week 1 [Day 1]), Week 16
description: AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.
measure: Change From Baseline at Week 16 in Burden Interview (BI) Scores
time frame: Baseline, Week 16
description: BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.
measure: Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)
time frame: Baseline, Week 16
description: MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.
arm group label: Galantamine
description: Patients will receive galantamine 8 mg/day for the first 4 weeks and the dose of galantamine will be increased up to 24 mg (if tolerable).
intervention type: Drug
intervention name: Galantamine
description: This is an observational study. Galantamine 8 mg/day will be administered for the first 4 weeks and later on the dose will increased up to 24 mg (if tolerable). Galantamine dose will be adjusted according to the investigator's discretion.
arm group label: Galantamine
other name: Razadyne
other name: Reminyl
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Korea, Ltd., Korea Clinical Trial
role: Study Director
affiliation: Janssen Korea, Ltd., Korea
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Caregiver Burden
mesh term: Galantamine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 