xml: <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/NCT05969054</url>
    </required_header>
    <id_info>
      <org_study_id>202306123</org_study_id>
      <nct_id>NCT05969054</nct_id>
    </id_info>
    <brief_title>Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy</brief_title>
    <official_title>A Clinical Study Exploring Lacosamide and Levetiracetam in Improving Cognitive in Patients With Alzheimer's Disease and Epilepsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xiangya Hospital of Central South University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xiangya Hospital of Central South University</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>
        Participants will perform Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment&#xD;
        (MoCA), Clinical Dementia Rating (CDR), Alzheimer's disease assessment scale-cognitive&#xD;
        section (ADAS-Cog), Hamilton Anxiety Scale (HAMA) and Hamilton Depression Rating Scale (HAMD)&#xD;
        evaluation. The patients will be randomly divided into two groups, treated with lacosamide&#xD;
        and levetiracetam respectively, and maintained for 6 months.&#xD;
  &#xD;
        Researchers will compare the lacosamide group with the levetiracetam group to see if the&#xD;
        improvement of cognitive function in the two groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mini-Mental State Examination (MMSE)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mini-Mental State Examination (MMSE)</measure>
      <time_frame>1 month after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mini-Mental State Examination (MMSE)</measure>
      <time_frame>3 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mini-Mental State Examination (MMSE)</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 30, the higher score means a better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>1 month after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 30, the higher score means a better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>3 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 30, the higher score means a better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 30, the higher score means a better cognition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Dementia Rating (CDR)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Dementia Rating (CDR)</measure>
      <time_frame>1 month after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Dementia Rating (CDR)</measure>
      <time_frame>3 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Dementia Rating (CDR)</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale</measure>
      <time_frame>1 month after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale</measure>
      <time_frame>3 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>1 month after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>3 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Anxiety Scale (HAMA)</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Depression Scale (HAMD)</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Depression Scale (HAMD)</measure>
      <time_frame>1 month after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Depression Scale (HAMD)</measure>
      <time_frame>3 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton Depression Scale (HAMD)</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Seizure frequency</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>Record seizure frequency</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Seizure frequency</measure>
      <time_frame>1 month after enrollment</time_frame>
      <description>Record seizure frequency</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Seizure frequency</measure>
      <time_frame>3 months after enrollment</time_frame>
      <description>Record seizure frequency</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Seizure frequency</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>Record seizure frequency</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EEG discharge</measure>
      <time_frame>At the time of enrollment</time_frame>
      <description>Record interictal epileptic discharge under the 24-hour VEEG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EEG discharge</measure>
      <time_frame>1 month after enrollment</time_frame>
      <description>Record interictal epileptic discharge under the 24-hour VEEG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EEG discharge</measure>
      <time_frame>3 months after enrollment</time_frame>
      <description>Record interictal epileptic discharge under the 24-hour VEEG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EEG discharge</measure>
      <time_frame>6 months after enrollment</time_frame>
      <description>Record interictal epileptic discharge under the 24-hour VEEG</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Alzheimer Disease 3</condition>
    <condition>Epilepsy</condition>
    <arm_group>
      <arm_group_label>Group A: lacosamide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects who were randomly divided into group A took lacosamide for 6 months during treatment (initial dose was 50mg bid, maintained for one week and then increased to 100mg bid and maintained at this dose)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: levetiracetam</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects randomly divided into group B took levetiracetam for 6 months during treatment (initial dose was 250mg bid, maintained for one week and then increased to 500mg bid and maintained at this dose).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lacosamide 100 mg</intervention_name>
      <description>Subjects who were randomly divided into group A took lacosamide for 6 months during treatment (initial dose was 50mg bid, maintained for one week and then increased to 100mg bid and maintained at this dose)</description>
      <arm_group_label>Group A: lacosamide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Levetiracetam 250mg</intervention_name>
      <description>Subjects randomly divided into group B took levetiracetam for 6 months during treatment (initial dose was 250mg bid, maintained for one week and then increased to 500mg bid and maintained at this dose).</description>
      <arm_group_label>Group B: levetiracetam</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinically diagnosed as Alzheimer's disease and treated with cholinesterase&#xD;
               inhibitors;&#xD;
  &#xD;
            -  New seizures or subclinical epileptic discharges;&#xD;
  &#xD;
            -  Mini-Mental State Examination score ≥ 18 points, and/or Clinical Dementia Rating (CDR)&#xD;
               score &lt; 2 points;&#xD;
  &#xD;
            -  Sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Suffering from syncope, transient ischemic attack, hysteria attack, migraine and other&#xD;
               transient brain dysfunction;&#xD;
  &#xD;
            -  Serious medical disease (especially atrioventricular block) or mental illness;&#xD;
  &#xD;
            -  There are structural abnormalities related to epilepsy in other brain regions of&#xD;
               imaging&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Li Feng, PhD</last_name>
      <phone>86-13873123853</phone>
      <email>fenglihx@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410008</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li Feng, PhD</last_name>
        <phone>86-13873123853</phone>
        <email>fenglihx@163.com</email>
      </contact>
      <investigator>
        <last_name>Li Feng, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Xiangya Hospital of Central South University</investigator_affiliation>
      <investigator_full_name>Li Feng, MD, PhD</investigator_full_name>
      <investigator_title>Associate Professor Vice Direct of Neurology Teaching and Research Office</investigator_title>
    </responsible_party>
    <keyword>Alzheimer Disease</keyword>
    <keyword>Epilepsy</keyword>
    <keyword>lacosamide</keyword>
    <keyword>levetiracetam</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Epilepsy</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lacosamide</mesh_term>
      <mesh_term>Levetiracetam</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969054
  org study id: 202306123
  nct id: NCT05969054
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Participants will perform Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment
        (MoCA), Clinical Dementia Rating (CDR), Alzheimer's disease assessment scale-cognitive
        section (ADAS-Cog), Hamilton Anxiety Scale (HAMA) and Hamilton Depression Rating Scale (HAMD)
        evaluation. The patients will be randomly divided into two groups, treated with lacosamide
        and levetiracetam respectively, and maintained for 6 months.
  
        Researchers will compare the lacosamide group with the levetiracetam group to see if the
        improvement of cognitive function in the two groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Mini-Mental State Examination (MMSE)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
  measure: Mini-Mental State Examination (MMSE)
  time frame: 1 month after enrollment
  description: The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
  measure: Mini-Mental State Examination (MMSE)
  time frame: 3 months after enrollment
  description: The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
  measure: Mini-Mental State Examination (MMSE)
  time frame: 6 months after enrollment
  description: The minimum value is 0, the maximum value is 30, the higher scores means a better cognition.
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: 1 month after enrollment
  description: The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: 3 months after enrollment
  description: The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: 6 months after enrollment
  description: The minimum value is 0, the maximum value is 30, the higher score means a better cognition.
  measure: Clinical Dementia Rating (CDR)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
  measure: Clinical Dementia Rating (CDR)
  time frame: 1 month after enrollment
  description: The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
  measure: Clinical Dementia Rating (CDR)
  time frame: 3 months after enrollment
  description: The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
  measure: Clinical Dementia Rating (CDR)
  time frame: 6 months after enrollment
  description: The minimum value is 0, the maximum value is 3, the higher scores means a great likelihood of dementia.
  measure: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
  measure: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
  time frame: 1 month after enrollment
  description: The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
  measure: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
  time frame: 3 months after enrollment
  description: The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
  measure: Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) scale
  time frame: 6 months after enrollment
  description: The minimum value is 0, the maximum value is 75, the higher scores means a great likelihood of dementia
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: 1 month after enrollment
  description: The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: 3 months after enrollment
  description: The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
  measure: Hamilton Anxiety Scale (HAMA)
  time frame: 6 months after enrollment
  description: The minimum value is 0, the maximum value is 56, the higher scores means a great likelihood of anxiety
  measure: Hamilton Depression Scale (HAMD)
  time frame: At the time of enrollment
  description: The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
  measure: Hamilton Depression Scale (HAMD)
  time frame: 1 month after enrollment
  description: The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
  measure: Hamilton Depression Scale (HAMD)
  time frame: 3 months after enrollment
  description: The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
  measure: Hamilton Depression Scale (HAMD)
  time frame: 6 months after enrollment
  description: The minimum value is 0, the maximum value is 77, the higher scores means a great likelihood of depression
  measure: Seizure frequency
  time frame: At the time of enrollment
  description: Record seizure frequency
  measure: Seizure frequency
  time frame: 1 month after enrollment
  description: Record seizure frequency
  measure: Seizure frequency
  time frame: 3 months after enrollment
  description: Record seizure frequency
  measure: Seizure frequency
  time frame: 6 months after enrollment
  description: Record seizure frequency
  measure: EEG discharge
  time frame: At the time of enrollment
  description: Record interictal epileptic discharge under the 24-hour VEEG
  measure: EEG discharge
  time frame: 1 month after enrollment
  description: Record interictal epileptic discharge under the 24-hour VEEG
  measure: EEG discharge
  time frame: 3 months after enrollment
  description: Record interictal epileptic discharge under the 24-hour VEEG
  measure: EEG discharge
  time frame: 6 months after enrollment
  description: Record interictal epileptic discharge under the 24-hour VEEG
  arm group label: Group A: lacosamide
  arm group type: Experimental
  description: Subjects who were randomly divided into group A took lacosamide for 6 months during treatment (initial dose was 50mg bid, maintained for one week and then increased to 100mg bid and maintained at this dose)
  arm group label: Group B: levetiracetam
  arm group type: Experimental
  description: Subjects randomly divided into group B took levetiracetam for 6 months during treatment (initial dose was 250mg bid, maintained for one week and then increased to 500mg bid and maintained at this dose).
  intervention type: Drug
  intervention name: Lacosamide 100 mg
  description: Subjects who were randomly divided into group A took lacosamide for 6 months during treatment (initial dose was 50mg bid, maintained for one week and then increased to 100mg bid and maintained at this dose)
  arm group label: Group A: lacosamide
  intervention type: Drug
  intervention name: Levetiracetam 250mg
  description: Subjects randomly divided into group B took levetiracetam for 6 months during treatment (initial dose was 250mg bid, maintained for one week and then increased to 500mg bid and maintained at this dose).
  arm group label: Group B: levetiracetam
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Li Feng, PhD
  phone: 86-13873123853
  email: fenglihx@163.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Xiangya Hospital of Central South University
  investigator full name: Li Feng, MD, PhD
  investigator title: Associate Professor Vice Direct of Neurology Teaching and Research Office
  mesh term: Alzheimer Disease
  mesh term: Epilepsy
  mesh term: Lacosamide
  mesh term: Levetiracetam