<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/NCT01715350</url>
  </required_header>
  <id_info>
    <org_study_id>PM012-P2</org_study_id>
    <nct_id>NCT01715350</nct_id>
  </id_info>
  <brief_title>Study to Explore the Optimal Dosage/Administration in Alzheimer's Disease</brief_title>
  <acronym>ADD</acronym>
  <official_title>A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease: Double-Blind, Randomized Between Placebo Control Group and Dose Groups, Parallel-Design, Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VTBIO Co. LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ADM Korea Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>VTBIO Co. LTD</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators intend to perform exploratory evaluation of the treatment effectiveness and&#xD;
      safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to&#xD;
      moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose&#xD;
      with placebo control for the efficacy and safety to explore the clinically optimal dose of&#xD;
      PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Period of study&#xD;
&#xD;
           -48 months from the date of KFDA approval of the protocol&#xD;
&#xD;
        2. Study subjects&#xD;
&#xD;
           -Patients with mild to moderate Alzheimer's disease&#xD;
&#xD;
        3. Study objectives&#xD;
&#xD;
             1. Primary objective&#xD;
&#xD;
                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on&#xD;
                     cognitive effect assessed by ADAS-cog at Week 12 post-dose&#xD;
&#xD;
             2. Secondary objectives&#xD;
&#xD;
                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on&#xD;
                     cognitive effect assessed by ADAS-cog at Week 8 post-dose&#xD;
&#xD;
                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on&#xD;
                     overall functional effect assessed by CDR at Weeks 8 and 12 post-dose&#xD;
&#xD;
                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on&#xD;
                     activities of daily living assessed by K-IADL at Weeks 8 and 12 post-dose&#xD;
&#xD;
                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on&#xD;
                     behavioral changes assessed by NPI at Weeks 8 and 12 post-dose&#xD;
&#xD;
                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on&#xD;
                     cognitive effect assessed by K-MMSE at Weeks 8 and 12 post-dose&#xD;
&#xD;
                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on&#xD;
                     improvement on VAS assessed by Senile Dementia Pattern Identification&#xD;
                     Diagnosis System at Weeks 8 and 12 post-dose&#xD;
&#xD;
        4. Study drug / Comparator&#xD;
&#xD;
           -650-mg PM012 Tablet by PuriMED Co., Ltd. / Placebo&#xD;
&#xD;
        5. Dosage/ Administration and Method of administration&#xD;
&#xD;
             1. Placebo group&#xD;
&#xD;
                  -  Morning:Placebo 2T, Evening:Placebo 2T&#xD;
&#xD;
             2. Dose group 1&#xD;
&#xD;
                  -  Morning:Placebo 1T+Study drug 1T, Evening:Placebo 1T+Study drug 1T&#xD;
&#xD;
             3. Dose group 2&#xD;
&#xD;
                  -  Morning:Study drug 2T, Evening:Study drug 2T&#xD;
&#xD;
             4. Study drug is 650-mg PM012 tablet&#xD;
&#xD;
             5. The drug will be taken with water within 30 minutes after breakfast and supper.&#xD;
&#xD;
             6. Even if no meal is taken, dosing will not be omitted and the drug should be taken&#xD;
                with enough amount of water.&#xD;
&#xD;
        6. Treatment duration&#xD;
&#xD;
           -12 weeks&#xD;
&#xD;
        7. Number of subjects&#xD;
&#xD;
             1. placebo group&#xD;
&#xD;
                  -  Efficacy population:42, Drop-out(20%)included:53&#xD;
&#xD;
             2. Dose group 1&#xD;
&#xD;
                  -  Efficacy population:42, Drop-out(20%)included:53&#xD;
&#xD;
             3. Dose group 2&#xD;
&#xD;
                  -  Efficacy population:42, Drop-out(20%)included:53&#xD;
&#xD;
             4. Total&#xD;
&#xD;
                  -  Efficacy population:126, Drop-out(20%)included:159&#xD;
&#xD;
        8. Study method&#xD;
&#xD;
             -  This study is designed to be a multicenter, randomized, double-blind, parallel&#xD;
                placebo group and 2 dose groups, phase 2 clinical study in patients with dementia&#xD;
                of Alzheimer's type aged ≥ 50 and ≤ 85 years.&#xD;
&#xD;
             -  Once a subject voluntarily provides the written consent to participate in the&#xD;
                study, he/she will be randomized only if meeting the inclusion criteria and&#xD;
                exclusion criteria through screening test. Randomized subjects will receive the&#xD;
                study drug or the placebo for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</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>ADAS-cog</measure>
    <time_frame>Week 12 post-dose</time_frame>
    <description>* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 12 post-dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ADAS-cog</measure>
    <time_frame>Weeks 8 post-dose</time_frame>
    <description>* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 8 post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CDR</measure>
    <time_frame>Weeks 8 and 12 post-dose</time_frame>
    <description>* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on overall functional effect assessed by CDR at Weeks 8 and 12 post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>K-IADL</measure>
    <time_frame>Weeks 8 and 12 post-dose</time_frame>
    <description>* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on activities of daily living assessed by K-IADL at Weeks 8 and 12 post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NPI</measure>
    <time_frame>Weeks 8 and 12 post-dose</time_frame>
    <description>* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on behavioral changes assessed by NPI at Weeks 8 and 12 post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>K-MMSE</measure>
    <time_frame>Weeks 8 and 12 post-dose</time_frame>
    <description>* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by K-MMSE at Weeks 8 and 12 post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>at Weeks 8 and 12 post-dose</time_frame>
    <description>* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on improvement on VAS assessed by Senile Dementia Pattern Identification Diagnosis System at Weeks 8 and 12 post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>while the subject is receiving the treatment</time_frame>
    <description>* To compare the safety based on treatment-emergent adverse events, laboratory tests (hematology/blood chemistry, urinalysis), physical examination, vital signs</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>• Drug : Placebo 2 tablet&#xD;
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug : Placebo 1 tablet + Study drug 1 tablet&#xD;
Study drug(650-mg PM012 tablet)&#xD;
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug : Study drug 2 tablet&#xD;
Study drug (650-mg PM012 tablet)&#xD;
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PM012</intervention_name>
    <description>The drug will be taken with water within 30 minutes after breakfast and supper.&#xD;
650mg/1 tablet, PO, 12weeks</description>
    <arm_group_label>Dose group 1</arm_group_label>
    <arm_group_label>Dose group 2</arm_group_label>
    <other_name>650-mg PM012 tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The drug will be taken with water within 30 minutes after breakfast and supper.&#xD;
650mg/1 tablet, PO, 12weeks</description>
    <arm_group_label>Dose group 1</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Placebo (for PM012)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1)Male and female patients aged ≥ 50 and ≤ 85 years&#xD;
&#xD;
          -  2)Clinically diagnosed with probable Alzheimer's disease based on DSM-IV and&#xD;
             NINCDS-ADRDA criteria&#xD;
&#xD;
          -  3)K-MMSE score of 12~26 at screening visit&#xD;
&#xD;
          -  4)For females: 2 years of confirmed menopause or surgical sterilization.&#xD;
&#xD;
          -  5)Able to walk (including the use of aids)&#xD;
&#xD;
          -  6)Able to perform procedures for cognitive and other tests&#xD;
&#xD;
          -  7)Residing with a life-long guardian willing to accompany the subject's on all visits,&#xD;
             oversee his/her compliance with the procedures specified in the protocol and the study&#xD;
             drug, and report his/her condition.&#xD;
&#xD;
          -  8)Having signed him/herself or his/her legally acceptable representative having signed&#xD;
             the written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1)Possible, probable, or definite vascular dementia by NINDS-AIREN criteria&#xD;
&#xD;
          -  2)History and/or evidence (result of CT or MRI performed within the past 12 months or&#xD;
             at screening) of other CNS disease (cerebrovascular disease, structural or&#xD;
             developmental anomaly, epilepsy, contagious, degenerative or infectious/demyelinating&#xD;
             CNS condition) as a cause of dementia&#xD;
&#xD;
          -  3)Delusion, delirium, epilepsy and other neurological pathology on neurological&#xD;
             examination&#xD;
&#xD;
          -  4)Abnormal test result on vitamin B12, syphilis serology, and thyroid stimulating&#xD;
             hormone (TSH) tests that are thought to contribute to the subject's dementia severity&#xD;
             or be a cause of dementia&#xD;
&#xD;
          -  5)History of significant psychiatric disease such as schizophrenia or bipolar&#xD;
             affective disorder that may interfere with the participation in this study in the&#xD;
             opinion of the investigator, or current depression (GDS ≥ 18)&#xD;
&#xD;
          -  6)Past history of known or suspected seizures including febrile convulsion,&#xD;
             unexplained recent unconsciousness or past history of significant head trauma with&#xD;
             unconsciousness.&#xD;
&#xD;
          -  7)Gastrointestinal, endocrine and cardiovascular disease not controlled by diet or&#xD;
             pharmacologic therapy&#xD;
&#xD;
          -  8)Cardiac disease such as myocardial infarction or valvular disease of heart,&#xD;
             arrhythmia within 3 months of the study start&#xD;
&#xD;
          -  9)Diabetes mellitus not controlled by hypoglycemic agent or insulin-dependent diabetes&#xD;
             mellitus&#xD;
&#xD;
          -  10)Past history of alcohol or other drug abuse&#xD;
&#xD;
          -  11)Having taken acetylcholinesterase inhibitor or memantine within the past 3 months&#xD;
&#xD;
          -  12)Hypertension with systolic blood pressure of &gt; 165 mmHg or diastolic blood pressure&#xD;
             of &gt; 96 mmHg&#xD;
&#xD;
          -  13)Severe renal impairment (serum creatinine ≥ 1.7 mg/dl)&#xD;
&#xD;
          -  14)Severe hepatic impairment (ALT, AST, or bilirubin ≥ 2.0 x upper limit of normal)&#xD;
&#xD;
          -  15)Is taking or expected to take disallowed concomitant medication&#xD;
&#xD;
          -  16)History of clinically significant drug hypersensitivity&#xD;
&#xD;
          -  17)Is ineligible to participate in this study in the judgment of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seoung-Hun Cho, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyung Hee University Oriental Medicine Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chang-Uk Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Catholic University of Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hyun-Kook Lim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Vincent's Hospital, Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jun-Hong Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Health Insurance Service Ilsan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyung Hee University Oriental Medicine Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Dongdaemun-gu</state>
        <zip>130-872</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Health Insurance Corporation Ilsan Hospital</name>
      <address>
        <city>Goyang</city>
        <state>Ilsandong-gu</state>
        <zip>410-719</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Vincent's Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Paldal-gu</state>
        <zip>442-72</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seocho-gu</state>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://www.kfda.go.kr</url>
    <description>Korea Food &amp; Drug Administration</description>
  </link>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 15, 2016</last_update_submitted>
  <last_update_submitted_qc>April 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's Disease</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/NCT01715350
org study id: PM012-P2
nct id: NCT01715350
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators intend to perform exploratory evaluation of the treatment effectiveness and
      safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to
      moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose
      with placebo control for the efficacy and safety to explore the clinically optimal dose of
      PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.
1. Period of study

           -48 months from the date of KFDA approval of the protocol

        2. Study subjects

           -Patients with mild to moderate Alzheimer's disease

        3. Study objectives

             1. Primary objective

                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on
                     cognitive effect assessed by ADAS-cog at Week 12 post-dose

             2. Secondary objectives

                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on
                     cognitive effect assessed by ADAS-cog at Week 8 post-dose

                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on
                     overall functional effect assessed by CDR at Weeks 8 and 12 post-dose

                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on
                     activities of daily living assessed by K-IADL at Weeks 8 and 12 post-dose

                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on
                     behavioral changes assessed by NPI at Weeks 8 and 12 post-dose

                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on
                     cognitive effect assessed by K-MMSE at Weeks 8 and 12 post-dose

                  -  To compare the efficacy of 2 doses of PM012 Tablet and placebo based on
                     improvement on VAS assessed by Senile Dementia Pattern Identification
                     Diagnosis System at Weeks 8 and 12 post-dose

        4. Study drug / Comparator

           -650-mg PM012 Tablet by PuriMED Co., Ltd. / Placebo

        5. Dosage/ Administration and Method of administration

             1. Placebo group

                  -  Morning:Placebo 2T, Evening:Placebo 2T

             2. Dose group 1

                  -  Morning:Placebo 1T+Study drug 1T, Evening:Placebo 1T+Study drug 1T

             3. Dose group 2

                  -  Morning:Study drug 2T, Evening:Study drug 2T

             4. Study drug is 650-mg PM012 tablet

             5. The drug will be taken with water within 30 minutes after breakfast and supper.

             6. Even if no meal is taken, dosing will not be omitted and the drug should be taken
                with enough amount of water.

        6. Treatment duration

           -12 weeks

        7. Number of subjects

             1. placebo group

                  -  Efficacy population:42, Drop-out(20%)included:53

             2. Dose group 1

                  -  Efficacy population:42, Drop-out(20%)included:53

             3. Dose group 2

                  -  Efficacy population:42, Drop-out(20%)included:53

             4. Total

                  -  Efficacy population:126, Drop-out(20%)included:159

        8. Study method

             -  This study is designed to be a multicenter, randomized, double-blind, parallel
                placebo group and 2 dose groups, phase 2 clinical study in patients with dementia
                of Alzheimer's type aged ≥ 50 and ≤ 85 years.

             -  Once a subject voluntarily provides the written consent to participate in the
                study, he/she will be randomized only if meeting the inclusion criteria and
                exclusion criteria through screening test. Randomized subjects will receive the
                study drug or the placebo for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ADAS-cog
time frame: Week 12 post-dose
description: * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 12 post-dose
measure: ADAS-cog
time frame: Weeks 8 post-dose
description: * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 8 post-dose
measure: CDR
time frame: Weeks 8 and 12 post-dose
description: * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on overall functional effect assessed by CDR at Weeks 8 and 12 post-dose
measure: K-IADL
time frame: Weeks 8 and 12 post-dose
description: * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on activities of daily living assessed by K-IADL at Weeks 8 and 12 post-dose
measure: NPI
time frame: Weeks 8 and 12 post-dose
description: * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on behavioral changes assessed by NPI at Weeks 8 and 12 post-dose
measure: K-MMSE
time frame: Weeks 8 and 12 post-dose
description: * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by K-MMSE at Weeks 8 and 12 post-dose
measure: VAS
time frame: at Weeks 8 and 12 post-dose
description: * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on improvement on VAS assessed by Senile Dementia Pattern Identification Diagnosis System at Weeks 8 and 12 post-dose
measure: AE
time frame: while the subject is receiving the treatment
description: * To compare the safety based on treatment-emergent adverse events, laboratory tests (hematology/blood chemistry, urinalysis), physical examination, vital signs
arm group label: Placebo group
arm group type: Placebo Comparator
description: • Drug : Placebo 2 tablet
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
arm group label: Dose group 1
arm group type: Experimental
description: Drug : Placebo 1 tablet + Study drug 1 tablet
Study drug(650-mg PM012 tablet)
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
arm group label: Dose group 2
arm group type: Experimental
description: Drug : Study drug 2 tablet
Study drug (650-mg PM012 tablet)
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
intervention type: Drug
intervention name: PM012
description: The drug will be taken with water within 30 minutes after breakfast and supper.
650mg/1 tablet, PO, 12weeks
arm group label: Dose group 1
arm group label: Dose group 2
other name: 650-mg PM012 tablet
intervention type: Drug
intervention name: Placebo
description: The drug will be taken with water within 30 minutes after breakfast and supper.
650mg/1 tablet, PO, 12weeks
arm group label: Dose group 1
arm group label: Placebo group
other name: Placebo (for PM012)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Seoung-Hun Cho, M.D.
role: Principal Investigator
affiliation: Kyung Hee University Oriental Medicine Hospital
last name: Chang-Uk Lee, M.D.
role: Principal Investigator
affiliation: The Catholic University of Korea
last name: Hyun-Kook Lim, M.D.
role: Principal Investigator
affiliation: Saint Vincent's Hospital, Korea
last name: Jun-Hong Lee, M.D.
role: Principal Investigator
affiliation: National Health Insurance Service Ilsan Hospital
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
url: http://www.kfda.go.kr
description: Korea Food & Drug Administration
responsible party type: Sponsor
mesh term: Alzheimer Disease