<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/NCT02239003</url>
  </required_header>
  <id_info>
    <org_study_id>103-3642C</org_study_id>
    <nct_id>NCT02239003</nct_id>
  </id_info>
  <brief_title>NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <brief_summary>
    <textblock>
      NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were&#xD;
      found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This&#xD;
      study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be&#xD;
      allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d);&#xD;
      (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may&#xD;
      yield better efficacy than placebo for cognitive function in patients with mild cognitive&#xD;
      impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24</measure>
    <time_frame>week 0, 8, 16, 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in speed of processing (Category Fluency) at week 24</measure>
    <time_frame>week 0, 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24</measure>
    <time_frame>week 8, 16, 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24</measure>
    <time_frame>week 0, 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24</measure>
    <time_frame>week 0, 24</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>DAOIB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250-1500 mg/day, oral, for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo, oral, for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAOIB</intervention_name>
    <arm_group_label>DAOIB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of mild cognitive impairment&#xD;
&#xD;
          -  MMSE between 17-26&#xD;
&#xD;
          -  CDR 0.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hachinski Ischemic Score &gt; 4&#xD;
&#xD;
          -  Substance abuse/dependence&#xD;
&#xD;
          -  Parkinson disease, epilepsy, dementia with psychotic features&#xD;
&#xD;
          -  Major depressive disorder&#xD;
&#xD;
          -  Major physical illnesses&#xD;
&#xD;
          -  Severe visual or hearing impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chieh-Hsin Lin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hsien-Yuan Lane, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>China Medical University, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>886</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chieh-Hsin Lin</investigator_full_name>
    <investigator_title>Dr</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>
  <!-- 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/NCT02239003
org study id: 103-3642C
nct id: NCT02239003
lead sponsor: 
NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were
      found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This
      study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be
      allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d);
      (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may
      yield better efficacy than placebo for cognitive function in patients with mild cognitive
      impairment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
time frame: week 0, 8, 16, 24
measure: Change from baseline in speed of processing (Category Fluency) at week 24
time frame: week 0, 24
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24
time frame: week 8, 16, 24
measure: Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24
time frame: week 0, 24
measure: Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24
time frame: week 0, 24
arm group label: DAOIB
arm group type: Experimental
description: 250-1500 mg/day, oral, for 24 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo, oral, for 24 weeks
intervention type: Drug
intervention name: DAOIB
arm group label: DAOIB
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Chieh-Hsin Lin, MD, PhD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Hsien-Yuan Lane, MD, PhD
role: Study Chair
affiliation: China Medical University, China
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Chieh-Hsin Lin
investigator title: Dr
mesh term: Cognitive Dysfunction