<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/NCT03752463</url>
  </required_header>
  <id_info>
    <org_study_id>105-3412C</org_study_id>
    <nct_id>NCT03752463</nct_id>
  </id_info>
  <brief_title>NMDA Enhancer for the Treatment of Mild Alzheimer's Disease</brief_title>
  <official_title>NMDA Enhancer for the Treatment of Mild Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR)&#xD;
      were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This&#xD;
      study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy&#xD;
      of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2)&#xD;
      DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The&#xD;
      investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive&#xD;
      function in patients with AD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2015</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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, Outcomes Assessor)</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>
    <description>Cognitive assessment</description>
  </primary_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>
    <description>Global assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in speed of processing (Category Fluency) at week 24</measure>
    <time_frame>week 0, 24</time_frame>
    <description>Cognitive assessment</description>
  </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>
    <description>Cognitive assessment</description>
  </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>
    <description>Cognitive assessment</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>DAOI-A group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>DAOI-B group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>DAOI-C group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAOI-A group</intervention_name>
    <description>DAOI with A dose</description>
    <arm_group_label>DAOI-A group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAOI-B group</intervention_name>
    <description>DAOI with B dose</description>
    <arm_group_label>DAOI-B group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAOI-C group</intervention_name>
    <description>DAOI with C dose</description>
    <arm_group_label>DAOI-C group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Alzheimer's disease&#xD;
&#xD;
          -  MMSE between 10-26&#xD;
&#xD;
          -  CDR 1&#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>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>August 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03752463
org study id: 105-3412C
nct id: NCT03752463
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR)
      were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This
      study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy
      of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2)
      DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The
      investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive
      function in patients with AD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
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
description: Cognitive assessment
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
description: Global assessment
measure: Change from baseline in speed of processing (Category Fluency) at week 24
time frame: week 0, 24
description: Cognitive assessment
measure: Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24
time frame: week 0, 24
description: Cognitive assessment
measure: Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24
time frame: week 0, 24
description: Cognitive assessment
arm group label: DAOI-A group
arm group type: Experimental
arm group label: DAOI-B group
arm group type: Experimental
arm group label: DAOI-C group
arm group type: Experimental
arm group label: Placebo group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: DAOI-A group
description: DAOI with A dose
arm group label: DAOI-A group
intervention type: Drug
intervention name: DAOI-B group
description: DAOI with B dose
arm group label: DAOI-B group
intervention type: Drug
intervention name: DAOI-C group
description: DAOI with C dose
arm group label: DAOI-C group
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo
arm group label: Placebo group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Alzheimer Disease