Study to Explore the Optimal Dosage/Administration in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): PM012; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The drug will be taken with water within 30 minutes after breakfast and supper.
650mg/1 tablet, PO, 12weeks; The drug will be taken with water within 30 minutes after breakfast and supper.
650mg/1 tablet, PO, 12weeks
Other intervention name(s): 650-mg PM012 tablet; Placebo (for PM012)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease