<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/NCT03038035</url>
  </required_header>
  <id_info>
    <org_study_id>MLC901-2</org_study_id>
    <nct_id>NCT03038035</nct_id>
  </id_info>
  <brief_title>The Alzheimer's Disease THErapy With NEuroaid (ATHENE) Study</brief_title>
  <acronym>ATHENE</acronym>
  <official_title>The Alzheimer's Disease THErapy With NEuroaid (ATHENE) Study : Assessing the Safety and Efficacy of Neuroaid II (MLC901) in Patients With Mild to Moderate Alzheimer's Disease Stable on Cholinesterase Inhibitors or Memantine: A Randomized, Double Blind, Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MLC601 (Neuroaid) is a Traditional Chinese Medicine (TCM) having neuroprotective and&#xD;
      neuroproliferative properties in cellular and animal models of brain injury. It contains 9&#xD;
      herbal and 5 non-herbal components. MLC901 (Neuroaid II), a simplified formula of MLC601,&#xD;
      containing only the 9 herbal components yet showing the same efficacy has become available.&#xD;
&#xD;
      This study is carried out to find out if NEUROAID II (MLC901) is safe to be taken together&#xD;
      with other established medicines for Alzheimer's disease and whether NEUROAID II (MLC901)&#xD;
      helps in slowing down the Alzheimer's disease progression.&#xD;
&#xD;
      This study will be a 6-month randomized, double-blind, placebo-controlled trial, followed by&#xD;
      an open extension study in which all subjects who completed the main 6 month trial&#xD;
      (irrespective of treatment allocation) will be offered open-labelled MLC901 for another 6&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluating the safety of MLC901 when it is given in combination with the standard treatment.The safety will be evaluated by adverse events, vital signs, ECG and laboratory tests, physical and neurological examinations at 6 months.</measure>
    <time_frame>week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of MLC901 as add on therapy to standard treatments for 6 months on cognitive function in patients with mild to moderate AD using Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS- Cog).</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of MLC901 as add on therapy to standard treatments for 6 months on cognitive function in patients with mild to moderate AD using Mini Mental State Examination (MMSE).</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the long term safety of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study with adverse events, vital signs, ECG and laboratory tests, physical and neurological examination at 1 year.</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS- CGIC).</measure>
    <time_frame>week 48</time_frame>
    <description>Using all of the other results (ADCS- ADL23, NPI, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS- ADL23)</measure>
    <time_frame>week 48</time_frame>
    <description>Using all of the other results (ADCS-CGIC, NPI, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Neuropsychiatric Inventory (NPI).</measure>
    <time_frame>week 48</time_frame>
    <description>Using all of the other results (ADCS-CGIC, ADCS-ADL23, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>MLC901</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NeuroAid II MLC901 is a derivative product of NeuroAid MLC601. It is a simplified formula based on the 9 Herbal ingredients that are present in NeuroAid MLC 601. Neuroaid II has been approved for sale as a Chinese Proprietary Medicine in Singapore by the HSA since March 2010. 24 weeks intervention. Dosage: 2 capsules 3 times a a day&#xD;
Upon completion of 24 weeks, subject will be given an option to continue an open-label extension for another 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>24 weeks intervention with orally placebo. 2 capsules 3 times a day.&#xD;
Upon completion of 24 weeks, subject will be given an option to continue an open-label extension for another 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MLC901</intervention_name>
    <description>24 weeks intervention with orally MLC901. 2 capsules 3 times a day</description>
    <arm_group_label>MLC901</arm_group_label>
    <other_name>Neuroaid II (MLC901)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>24 weeks intervention with orally placebo. 2 capsules 3 times a day</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>MLC901 matched Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age ≥50 years&#xD;
&#xD;
          -  Diagnosed with probable AD according to NINCDS-ADRDA criteria,&#xD;
&#xD;
          -  MMSE score of 10 to 24,&#xD;
&#xD;
          -  Receiving the same AChEI or Memantine for the past 6 months prior to screening and on&#xD;
             a stable dose for the past 4 months (stable dose is defined as 5 to 10mg/day for&#xD;
             Donepezil, 3, 4.5 or 6 mg twice daily for rivastigmine capsules, 4.6 or 9.5 mg for&#xD;
             rivastigmine transdermal patch once daily, 8 or 12 mg twice daily for galantamine&#xD;
             tablets, 16 to 24 mg once daily for galantamine capsules XL, 10 mg OD or 10 mg BD for&#xD;
             Memantine)&#xD;
&#xD;
          -  Patient or legal representative is able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving any investigational product within 60 days or 5 half-lives prior to&#xD;
             screening&#xD;
&#xD;
          -  Any serious medical or psychiatric condition which in the investigator's judgement may&#xD;
             jeopardize the patient by his/her participation in this study or may hamper his/her&#xD;
             ability to perform and complete procedures required in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Casuarine Low, BSc</last_name>
    <phone>66015666</phone>
    <email>casuarine_low@nuhs.edu.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Sg</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Casuarine Low, Bsc (Hons)</last_name>
      <phone>66015666</phone>
      <email>casuarine_low@nuhs.edu.sg</email>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</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/NCT03038035
org study id: MLC901-2
nct id: NCT03038035
lead sponsor: 
has dmc: Yes
MLC601 (Neuroaid) is a Traditional Chinese Medicine (TCM) having neuroprotective and
      neuroproliferative properties in cellular and animal models of brain injury. It contains 9
      herbal and 5 non-herbal components. MLC901 (Neuroaid II), a simplified formula of MLC601,
      containing only the 9 herbal components yet showing the same efficacy has become available.

      This study is carried out to find out if NEUROAID II (MLC901) is safe to be taken together
      with other established medicines for Alzheimer's disease and whether NEUROAID II (MLC901)
      helps in slowing down the Alzheimer's disease progression.

      This study will be a 6-month randomized, double-blind, placebo-controlled trial, followed by
      an open extension study in which all subjects who completed the main 6 month trial
      (irrespective of treatment allocation) will be offered open-labelled MLC901 for another 6
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Evaluating the safety of MLC901 when it is given in combination with the standard treatment.The safety will be evaluated by adverse events, vital signs, ECG and laboratory tests, physical and neurological examinations at 6 months.
time frame: week 24
measure: Evaluate the effect of MLC901 as add on therapy to standard treatments for 6 months on cognitive function in patients with mild to moderate AD using Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS- Cog).
time frame: week 24
measure: Evaluate the effect of MLC901 as add on therapy to standard treatments for 6 months on cognitive function in patients with mild to moderate AD using Mini Mental State Examination (MMSE).
time frame: week 24
measure: Evaluate the long term safety of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study with adverse events, vital signs, ECG and laboratory tests, physical and neurological examination at 1 year.
time frame: week 48
measure: Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS- CGIC).
time frame: week 48
description: Using all of the other results (ADCS- ADL23, NPI, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.
measure: Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS- ADL23)
time frame: week 48
description: Using all of the other results (ADCS-CGIC, NPI, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.
measure: Evaluate the long term effect on disease progression of MLC901 as add-on treatment to standard treatments for up to 1 year in an open extension study by assessing Neuropsychiatric Inventory (NPI).
time frame: week 48
description: Using all of the other results (ADCS-CGIC, ADCS-ADL23, ADAS-Cog and MMSE) together would provide an accurate assessment of the disease progression.
arm group label: MLC901
arm group type: Active Comparator
description: NeuroAid II MLC901 is a derivative product of NeuroAid MLC601. It is a simplified formula based on the 9 Herbal ingredients that are present in NeuroAid MLC 601. Neuroaid II has been approved for sale as a Chinese Proprietary Medicine in Singapore by the HSA since March 2010. 24 weeks intervention. Dosage: 2 capsules 3 times a a day
Upon completion of 24 weeks, subject will be given an option to continue an open-label extension for another 24 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: 24 weeks intervention with orally placebo. 2 capsules 3 times a day.
Upon completion of 24 weeks, subject will be given an option to continue an open-label extension for another 24 weeks.
intervention type: Drug
intervention name: MLC901
description: 24 weeks intervention with orally MLC901. 2 capsules 3 times a day
arm group label: MLC901
other name: Neuroaid II (MLC901)
intervention type: Drug
intervention name: Placebo
description: 24 weeks intervention with orally placebo. 2 capsules 3 times a day
arm group label: Placebo
other name: MLC901 matched Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 120 Years
healthy volunteers: No
last name: Casuarine Low, BSc
phone: 66015666
email: casuarine_low@nuhs.edu.sg
facility: 
status: Recruiting
contact: 
country: Singapore
responsible party type: Sponsor
mesh term: Alzheimer Disease