<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/NCT01696123</url>
  </required_header>
  <id_info>
    <org_study_id>SBMU-1391</org_study_id>
    <nct_id>NCT01696123</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of MLC601 in Patients With Mild to Moderate Alzheimer Disease Who Were Unable to Tolerate or Failed to Benefit From Treatment With Rivastigmine</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University of Medical Sciences</source>
  <brief_summary>
    <textblock>
      Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer&#xD;
      disease (AD) offer limited and often transient symptomatic benefits to patients but do not&#xD;
      mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate&#xD;
      Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate&#xD;
      Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with&#xD;
      Rivastigmine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An 18-month open-label pilot study would be conducted at three university referral centres in&#xD;
      Tehran, Iran. All patients are at least 50 years old, met the criteria for AD according to&#xD;
      the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and&#xD;
      failed treatment with the cholinesterase inhibitor Rivastigmine for any reason. A baseline&#xD;
      medical history will be taken and physical examination will be performed for all&#xD;
      participants, and any comorbidities and concomitant therapies would be noted. Patients with&#xD;
      controlled concomitant diseases, such as hypertension and diabetes, will be allowed to enter&#xD;
      the study. Mini-Mental State Examination (MMSE)10 and Alzheimer disease assessment&#xD;
      scale-cognitive sub scale11 (ADAS-cog) will be used to measure treatment efficacy. MLC601&#xD;
      will be prescribed as one capsule three times daily without an escalation dose. Safety and&#xD;
      tolerability evaluations included physical examinations, electrocardiography, vital sign&#xD;
      monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter.&#xD;
      The MMSE and ADAS-cog will be recorded at each efficacy follow-up visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements</measure>
    <time_frame>every 4 weeks up to 18 months</time_frame>
    <description>change in the Mini-Mental State Examination (MMSE) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements</measure>
    <time_frame>every 4 weeks up to 18 months</time_frame>
    <description>change in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>to measure included adverse events (AEs)</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>Safety and tolerability evaluations included physical examinations, electrocardiography, vital sign monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter. AEs were defined as any sign, symptom, syndrome or disease that occurred for the first time or worsened after baseline, whether they were considered treatment related.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>measuring withdrawal rate</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>measuring any withdrawal rate among intervention group</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>MLC601</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MLC601 (NeuroAid, Moleac Pte. Ltd, Singapore) (0.4 g per capsule) was prescribed as one capsule three times daily without an escalation dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MLC601</intervention_name>
    <description>It was described</description>
    <arm_group_label>MLC601</arm_group_label>
    <other_name>NeuroAid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 50 years old&#xD;
&#xD;
          -  met the criteria for AD according to the fourth edition of the Diagnostic and&#xD;
             Statistical Manual of Mental Disorders (DSM-IV)&#xD;
&#xD;
          -  failed treatment with the cholinesterase inhibitor Rivastigmine for any reason&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled diabetes mellitus&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  unstable cardiac disease&#xD;
&#xD;
          -  severe obstructive pulmonary disease&#xD;
&#xD;
          -  renal or hepatic failure&#xD;
&#xD;
          -  and/or other life threatening conditions&#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>Ali Amini, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shahid Beheshti University of Medical Sciences, Tehran, Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loghman Hospital</name>
      <address>
        <city>Tehran</city>
        <zip>1315693446</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Ali Amini Harandi</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Alzheimer disease</keyword>
  <keyword>Cholinesterase inhibitors</keyword>
  <keyword>MLC601</keyword>
  <keyword>NeuroAiD</keyword>
  <keyword>neuroprotection</keyword>
  <keyword>neuroregeneration</keyword>
  <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/NCT01696123
org study id: SBMU-1391
nct id: NCT01696123
lead sponsor: 
Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer
      disease (AD) offer limited and often transient symptomatic benefits to patients but do not
      mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate
      Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate
      Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with
      Rivastigmine.
An 18-month open-label pilot study would be conducted at three university referral centres in
      Tehran, Iran. All patients are at least 50 years old, met the criteria for AD according to
      the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and
      failed treatment with the cholinesterase inhibitor Rivastigmine for any reason. A baseline
      medical history will be taken and physical examination will be performed for all
      participants, and any comorbidities and concomitant therapies would be noted. Patients with
      controlled concomitant diseases, such as hypertension and diabetes, will be allowed to enter
      the study. Mini-Mental State Examination (MMSE)10 and Alzheimer disease assessment
      scale-cognitive sub scale11 (ADAS-cog) will be used to measure treatment efficacy. MLC601
      will be prescribed as one capsule three times daily without an escalation dose. Safety and
      tolerability evaluations included physical examinations, electrocardiography, vital sign
      monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter.
      The MMSE and ADAS-cog will be recorded at each efficacy follow-up visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements
time frame: every 4 weeks up to 18 months
description: change in the Mini-Mental State Examination (MMSE) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.
measure: changes in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements
time frame: every 4 weeks up to 18 months
description: change in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.
measure: to measure included adverse events (AEs)
time frame: every 4 weeks
description: Safety and tolerability evaluations included physical examinations, electrocardiography, vital sign monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter. AEs were defined as any sign, symptom, syndrome or disease that occurred for the first time or worsened after baseline, whether they were considered treatment related.
measure: measuring withdrawal rate
time frame: every 4 weeks
description: measuring any withdrawal rate among intervention group
arm group label: MLC601
arm group type: Experimental
description: MLC601 (NeuroAid, Moleac Pte. Ltd, Singapore) (0.4 g per capsule) was prescribed as one capsule three times daily without an escalation dose.
intervention type: Drug
intervention name: MLC601
description: It was described
arm group label: MLC601
other name: NeuroAid
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ali Amini, M.D
role: Principal Investigator
affiliation: Shahid Beheshti University of Medical Sciences, Tehran, Iran
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University of Medical Sciences
investigator full name: Ali Amini Harandi
investigator title: Dr
mesh term: Alzheimer Disease