<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/NCT02253043</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-002</org_study_id>
    <nct_id>NCT02253043</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease</brief_title>
  <official_title>The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Pins Medical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Pins Medical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: The purpose of this clinical study is to verify the long term effectiveness and&#xD;
      safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd.&#xD;
      as a treatment option for patients with cognitive, behavioral, and functional disability of&#xD;
      Alzheimer's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS&#xD;
      Deep Brain Stimulation Device for 12 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)</measure>
    <time_frame>12 month</time_frame>
    <description>Change from Baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Dementia Rating Scale</measure>
    <time_frame>12 month</time_frame>
    <description>Change from Baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DBS Implant and stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)</intervention_name>
    <description>PINS Stimulator System</description>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <other_name>Deep Brain Stimulation Device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is aged 40 to 80 years old;&#xD;
&#xD;
          2. Subject with AD diagnosed according to the criteria for probable AD as defined by the&#xD;
             National Institute of Neurological Disorders and Stroke-Alzheimer's Disease and&#xD;
             Related Disorders Association (NINCDS-ADRDA);&#xD;
&#xD;
          3. Subject have received the diagnosis of AD within the past 2 years;&#xD;
&#xD;
          4. Subject have a CDR of 0.5 or 1.0;&#xD;
&#xD;
          5. Score between 20 and 28 on the Mini Mental State Examination&#xD;
&#xD;
          6. have been taking a stable dose of cholinesterase inhibitors for a minimum of 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with hearing impairment;&#xD;
&#xD;
          2. Failures of important organs and in severe conditions&#xD;
&#xD;
          3. Be reluctant or disabled to receive neuropsychological assessments;&#xD;
&#xD;
          4. Participate in other clinical trial;&#xD;
&#xD;
          5. Has a life expectancy of &lt; 1 year.&#xD;
&#xD;
          6. The investigator and/or enrollment review committee, would preclude participation in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Luming, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Tsinghua University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jia Fumin, PhD</last_name>
    <phone>+86 13811534875</phone>
    <email>pins_medical@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jianguo Zhang, MD</last_name>
      <phone>010-67096611</phone>
      <email>Limuxin2011@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>301 Hospatl</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinguang Yu, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Zhipei Ling, MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>October 13, 2016</last_update_submitted>
  <last_update_submitted_qc>October 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 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/NCT02253043
org study id: PINS-002
nct id: NCT02253043
lead sponsor: 
collaborator: 
has dmc: Yes
Purpose: The purpose of this clinical study is to verify the long term effectiveness and
      safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd.
      as a treatment option for patients with cognitive, behavioral, and functional disability of
      Alzheimer's disease.
Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS
      Deep Brain Stimulation Device for 12 month.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
time frame: 12 month
description: Change from Baseline
measure: Clinical Dementia Rating Scale
time frame: 12 month
description: Change from Baseline
arm group label: Deep Brain Stimulation
arm group type: Experimental
description: DBS Implant and stimulation
intervention type: Device
intervention name: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)
description: PINS Stimulator System
arm group label: Deep Brain Stimulation
other name: Deep Brain Stimulation Device
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Li Luming, PhD
role: Study Chair
affiliation: Tsinghua University
last name: Jia Fumin, PhD
phone: +86 13811534875
email: pins_medical@163.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Alzheimer Disease