<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/NCT02982603</url>
  </required_header>
  <id_info>
    <org_study_id>Z12020286</org_study_id>
    <nct_id>NCT02982603</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment</brief_title>
  <official_title>The Efficacy and Safety of Qinggongshoutao Bolus for aMnestic Mild Cognitive Impairment: A 52- Week Randomized, Double-blind, Controlled,Three Arms, Multi-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dongzhimen Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dongzhimen Hospital, Beijing</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel&#xD;
      controlled phase VI trial being carried out in 20 centers around China. The study population&#xD;
      includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in&#xD;
      both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2&#xD;
      times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton)&#xD;
      (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo&#xD;
      identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a&#xD;
      52-weeks double-blind treatment period. The primary outcome measure is change from baseline&#xD;
      in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of&#xD;
      conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental&#xD;
      State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative&#xD;
      Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is&#xD;
      being assessed by observing side effects and adverse reaction during the entire treatment&#xD;
      period. Statistical analysis will be conducted according to per-protocol population and&#xD;
      intend-to-treat population and the safety will be analyzed in safety set.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale</measure>
    <time_frame>week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to end of double-blind treatment of rate of conversion to dementia</measure>
    <time_frame>week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination(MMSE)</measure>
    <time_frame>week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)</measure>
    <time_frame>week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24)</measure>
    <time_frame>week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Herbal Medicine Allergy</condition>
  <arm_group>
    <arm_group_label>Qinggongshoutao Bolus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761 .Qinggongshoutao bolus 70 pills every time (7g), 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ginkgo Biloba Extract 761</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ginkgo Biloba Extract 761 and placebo identified to Qinggongshoutao bolus.The subjects will take Ginkgo Biloba Extract 761 2 times per day, 2 pills per time(80mg) ,and identified to Qinggongshoutao bolus 70 pills every time, 2 times per day for 48 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebos</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761.Placebo identified to Qinggongshoutao bolus 70 pills every time, 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qinggongshoutao Bolus</intervention_name>
    <description>Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761</description>
    <arm_group_label>Qinggongshoutao Bolus</arm_group_label>
    <other_name>Ginkgo biloba also named Egb761 or Ginaton</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ginkgo Biloba Extract 761</intervention_name>
    <description>Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761</description>
    <arm_group_label>Ginkgo Biloba Extract 761</arm_group_label>
    <other_name>Ginkgo biloba also named Egb761 or Ginaton</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba</description>
    <arm_group_label>Placebos</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. cognitive complaints from the patients or their families;&#xD;
&#xD;
          2. objective evidence for memory impairment, delayed story recall test(DSR)&lt;12.6(age50-64&#xD;
             less than15.5,65-74less than 12.5,older 75 less than10);&#xD;
&#xD;
          3. normal general cognitive function, with Mini-Mental State Examination (MMSE) score of&#xD;
             between 24 and 30 (including 30);&#xD;
&#xD;
          4. preservation of activities of daily living, with Alzheimer's Disease Cooperative&#xD;
             Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) score&#xD;
             between 38 and 52;&#xD;
&#xD;
          5. cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating&#xD;
             scale=0.5,memory domain = 0.5;&#xD;
&#xD;
          6. absence of dementia, not sufficiently impaired cognitively and functionally to meet&#xD;
             DSM-IV criteria,&#xD;
&#xD;
          7. enough vision and hearing to accomplishment neuropsychological test;&#xD;
&#xD;
          8. capability to read words and write simple sentence;&#xD;
&#xD;
          9. capability and willingness to give informed consent and to comply with the study&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. non amnestic Mild cognitive impairment;&#xD;
&#xD;
          2. meeting the diagnostic criteria for dementia;&#xD;
&#xD;
          3. cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral&#xD;
             damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as&#xD;
             meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or&#xD;
             a brain tumor ,or drug abuse or alcohol abuse&#xD;
&#xD;
          4. having significant psychiatric disease, depression, the Hamilton depression scale &gt;12;&#xD;
             CT or MRI scan showed central nervous system infections Infarction or focal lesions&#xD;
             within 12 months，the Hachinski Ischemic Scale (HIS)&gt;4;&#xD;
&#xD;
          5. combined following disease: diabetes; poor controlled hypertension or severe&#xD;
             arrhythmias; or suffered from heart infarction within 3 months; severe asthma or COPD;&#xD;
             severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer;&#xD;
&#xD;
          6. used cholinesterase inhibitors or memantine within 1 month;&#xD;
&#xD;
          7. history of hypersensitivity to the treatment drugs;&#xD;
&#xD;
          8. concomitant drugs with the potential to interfere with cognition;&#xD;
&#xD;
          9. administration of other investigational drugs; severe impairment of the functions of&#xD;
             the kidney or liver;&#xD;
&#xD;
         10. vegetarians or contraindications for animal innards.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinzhou Tian, M.D,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dongzhimen Hospital, Beijing University of Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dongzhimen Hospital ,Beijing University of Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dongzhimen Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>Jinzhou Tian</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02982603
org study id: Z12020286
nct id: NCT02982603
lead sponsor: 
has dmc: Yes
This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel
      controlled phase VI trial being carried out in 20 centers around China. The study population
      includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in
      both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2
      times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton)
      (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo
      identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a
      52-weeks double-blind treatment period. The primary outcome measure is change from baseline
      in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of
      conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental
      State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative
      Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is
      being assessed by observing side effects and adverse reaction during the entire treatment
      period. Statistical analysis will be conducted according to per-protocol population and
      intend-to-treat population and the safety will be analyzed in safety set.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale
time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
measure: Change from baseline to end of double-blind treatment of rate of conversion to dementia
time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
measure: Mini-Mental State Examination(MMSE)
time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
measure: Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)
time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
measure: Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24)
time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.
arm group label: Qinggongshoutao Bolus
arm group type: Experimental
description: Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761 .Qinggongshoutao bolus 70 pills every time (7g), 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.
arm group label: Ginkgo Biloba Extract 761
arm group type: Active Comparator
description: Ginkgo Biloba Extract 761 and placebo identified to Qinggongshoutao bolus.The subjects will take Ginkgo Biloba Extract 761 2 times per day, 2 pills per time(80mg) ,and identified to Qinggongshoutao bolus 70 pills every time, 2 times per day for 48 weeks.
arm group label: Placebos
arm group type: Placebo Comparator
description: Placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761.Placebo identified to Qinggongshoutao bolus 70 pills every time, 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.
intervention type: Drug
intervention name: Qinggongshoutao Bolus
description: Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761
arm group label: Qinggongshoutao Bolus
other name: Ginkgo biloba also named Egb761 or Ginaton
intervention type: Drug
intervention name: Ginkgo Biloba Extract 761
description: Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761
arm group label: Ginkgo Biloba Extract 761
other name: Ginkgo biloba also named Egb761 or Ginaton
intervention type: Drug
intervention name: Placebos
description: Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba
arm group label: Placebos
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jinzhou Tian, M.D,PhD
role: Principal Investigator
affiliation: Dongzhimen Hospital, Beijing University of Chinese Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Dongzhimen Hospital, Beijing
investigator full name: Jinzhou Tian
investigator title: Clinical Professor
mesh term: Cognitive Dysfunction
sharing ipd: No