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/NCT06008639</url>
    </required_header>
    <id_info>
      <org_study_id>2018YFC2001700</org_study_id>
      <nct_id>NCT06008639</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease</brief_title>
    <official_title>Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Danyang Huichuang Medical Equipment Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Danyang Huichuang Medical Equipment Co., Ltd.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To explore the efficacy and safety of near infrared light therapy for Alzheimer's disease.&#xD;
        Each subject will be numbered and their medical records will be established. The subjects&#xD;
        will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6&#xD;
        days a week) for 4 months while the treatment group is active settings and the control group&#xD;
        is sham settings.Follow-up visits will be conducted at 2 months, 4 months and 2 months after&#xD;
        treatment. At each follow-up, scale assessment, blood, MRI, and EEG were observed&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>The subjects will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6 days a week) for 4 months while the treatment group is active settings and the control group is sham settings.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in ADAS-cog</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog；The higher the score, the worse.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline in MMSE</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>(Mini-Mental State Examination, MMSE ;The higher the score, the better.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline in ALFF</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>The amplitudeof low-frequency fluctuations, ALFF;The increase of ALFF indicates that neuronal excitability and metabolism are enhanced, while the decrease of ALFF indicates that neuronal spontaneous activity is inhibited.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in MOCA</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>Montreal Cognitive Assessment, MoCA；The higher the score, the better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in ADCS-CGIC</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>Alzheimer's Disease Cooperative study-clinical global impression of change scale，ADCS-CGIC</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in ADCS-ADL</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>Alzheimer's Disease Cooperative study-Activities of Daily Living Scale，ADCS-ADL;The higher the score, the better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in NPI</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>Neuropaychiatic Inventory，NPI；The higher the score, the worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in HAMD</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>Hamilton depression scale,HAMD; The higher the score, the worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Aβ amyloid and tau levels</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>Plasma Aβ and Tau proteins are thought to be related to the pathogenesis of AD; The lower the protein level, the better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MRI</measure>
      <time_frame>8 weeks, 16 weeks and 24 weeks</time_frame>
      <description>Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Mild to Moderate Alzheimer's Disease</condition>
    <arm_group>
      <arm_group_label>treatment group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>active setting</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>sham setting</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>treatment group-Device: NirsCure - Active NirsCure - Active settings</intervention_name>
      <description>Treatment was performed once a day,5-6 times a week for 16 weeks.</description>
      <arm_group_label>treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>placebo group-Device: NirsCure - Sham NirsCure - Sham settings</intervention_name>
      <description>Treatment was performed once a day,5-6 times a week for 16 weeks.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The age of registration is 50-85 years old, male or female.&#xD;
  &#xD;
            -  The MMSE score &lt; 26 points can be used to complete the scale assessment.&#xD;
  &#xD;
            -  Patients who are not on medication and who are taking psychotropic or&#xD;
               cognitive-improving drugs must have a stable dose for at least 12 weeks before the&#xD;
               trial and remain the same for the duration of treatment.&#xD;
  &#xD;
            -  Agree to participate in the clinical trial, willing to maintain the original treatment&#xD;
               plan during the trial, and have signed the informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  MRI showed evidence of abnormalities other than Alzheimer's disease, such as cerebral&#xD;
               infarction at key sites and severe leukodystrophy (Fezakas&gt;Level 3).&#xD;
  &#xD;
            -  There are contraindications to MRI scanning, such as metal implants, claustrophobia,&#xD;
               etc.&#xD;
  &#xD;
            -  A history of stroke or seizures.&#xD;
  &#xD;
            -  Photosensitive to sunlight or visible light, eczema or increased sensitivity of the&#xD;
               skin at the treatment site.&#xD;
  &#xD;
            -  Severe vision or hearing impairment.&#xD;
  &#xD;
            -  Alcohol dependence, drug or other drug addiction or addiction tendency.&#xD;
  &#xD;
            -  During the study , subjects were pregnant, breastfeeding, or planning to pregnancy.&#xD;
  &#xD;
            -  He/She is currently participating in another study related to the treatment of AD.&#xD;
  &#xD;
            -  Researchers think that participants could not be included.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ping Ze Lv</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Sichuan</state>
          <zip>400000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06008639
  org study id: 2018YFC2001700
  nct id: NCT06008639
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To explore the efficacy and safety of near infrared light therapy for Alzheimer's disease.
        Each subject will be numbered and their medical records will be established. The subjects
        will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6
        days a week) for 4 months while the treatment group is active settings and the control group
        is sham settings.Follow-up visits will be conducted at 2 months, 4 months and 2 months after
        treatment. At each follow-up, scale assessment, blood, MRI, and EEG were observed
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The subjects will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6 days a week) for 4 months while the treatment group is active settings and the control group is sham settings.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Change from baseline in ADAS-cog
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog；The higher the score, the worse.
  measure: Change from baseline in MMSE
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: (Mini-Mental State Examination, MMSE ;The higher the score, the better.
  measure: Change from baseline in ALFF
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: The amplitudeof low-frequency fluctuations, ALFF;The increase of ALFF indicates that neuronal excitability and metabolism are enhanced, while the decrease of ALFF indicates that neuronal spontaneous activity is inhibited.
  measure: Change from baseline in MOCA
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: Montreal Cognitive Assessment, MoCA；The higher the score, the better.
  measure: Change from baseline in ADCS-CGIC
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: Alzheimer's Disease Cooperative study-clinical global impression of change scale，ADCS-CGIC
  measure: Change from baseline in ADCS-ADL
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: Alzheimer's Disease Cooperative study-Activities of Daily Living Scale，ADCS-ADL;The higher the score, the better.
  measure: Change from baseline in NPI
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: Neuropaychiatic Inventory，NPI；The higher the score, the worse.
  measure: Change from baseline in HAMD
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: Hamilton depression scale,HAMD; The higher the score, the worse.
  measure: Aβ amyloid and tau levels
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: Plasma Aβ and Tau proteins are thought to be related to the pathogenesis of AD; The lower the protein level, the better.
  measure: MRI
  time frame: 8 weeks, 16 weeks and 24 weeks
  description: Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed.
  arm group label: treatment group
  arm group type: Active Comparator
  description: active setting
  arm group label: Control group
  arm group type: Placebo Comparator
  description: sham setting
  intervention type: Device
  intervention name: treatment group-Device: NirsCure - Active NirsCure - Active settings
  description: Treatment was performed once a day,5-6 times a week for 16 weeks.
  arm group label: treatment group
  intervention type: Device
  intervention name: placebo group-Device: NirsCure - Sham NirsCure - Sham settings
  description: Treatment was performed once a day,5-6 times a week for 16 weeks.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ping Ze Lv
  role: Principal Investigator
  affiliation: Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  sharing ipd: No