To evaluate the safety and efficacy of PM012 tablets for Alzheimer's disease, dose-finding study will be performed on phase 2b, and the established dose will be used for the non-inferiority phase 3 trial to evaluate the investigational product's safety and efficacy: Double blind, randomized, active drug comparative, multi-center, parallel-group clinical trial
This study is to establish an effective therapeutic dose in Korean patients with a mild degree of Alzheimer's disease, by comparing the safety and efficacy of the investigational product PM012 tablet administered to the 2,600 mg /day group, 3,900 mg /day group, and 5,200 mg /day group, with the active drug Aricept 5 mg (donepezil hydrochloride) from Daewoong Pharmaceuticals administered to the active control group, for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
312
PM012 650 mg tablet drug
PM012 tablet placebo
Aricept 5 mg (donepezil hydrochloride) drug
Mediforum
Seoul, Seongdon-gu, South Korea
RECRUITINGADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
* To compare the efficacy of dose groups and active comparator group based on cognitive functions assessed through ADAS-cog at 12 weeks post-dose. * The total score ranges from 0 (no function) to 70 (maximal function), and the higher the score, the greater the cognitive impairment.
Time frame: At 12 weeks post-dose
ADCS-MCI-ADLI (Alzheimer's Disease Cooperative Study-Mild Cognitive Impairment- Activities of Daily Living Inventory)
* To compare the efficacy of dose groups and active comparator group based on activities of daily living assessed through ADCS-MCI-ADLI at 12 weeks post-dose * The total score ranges from 0 to 53, and the lower the score, the more the participant needs help with daily living.
Time frame: At 12 weeks post-dose
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
* To compare the efficacy of dose groups and active comparator group based on cognitive functions assessed through ADAS-cog at 8 weeks post-dose. * The total score ranges from 0 (no function) to 70 (maximal function), and the higher the score, the greater the cognitive impairment.
Time frame: At 8 weeks post-dose
ADCS-MCI-ADLI (Alzheimer's Disease Cooperative Study-Mild Cognitive Impairment-Activities of Daily Living Inventory)
* To compare the efficacy of dose groups and active comparator group based on activities of daily living assessed through ADCS-MCI-ADLI at 8 weeks post-dose. * The total score ranges from 0 to 53, and the lower the score, the more need to help with daily living.
Time frame: At 8 weeks post-dose
CDR (Clinical Dementia Rating)
* To compare the efficacy of dose groups and active comparator group based on overall function assessed through CDR at 8 weeks and 12 weeks post-dose. * Scores are on a scale of 0 - 5, with 0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia, 4 = profound dementia, and 5 = terminal dementia.
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Aricept 5 mg (donepezil hydrochloride) placebo
Time frame: At 8 weeks and 12 weeks post-dose
MMSE (Mini Mental State Examination)
* To compare the efficacy of dose groups and active comparator group based on cognitive functions assessed through MMSE at 8 weeks and 12 weeks post-dose. * The total score ranges from 0 to 30 and the lower the score, the more the cognitive problems.
Time frame: At 8 weeks and 12 weeks post-dose
NPI (Neuropsychiatric Inventory)
* To compare the efficacy of dose groups and active comparator group based on behavioral change assessed through NPI at 8 weeks and 12 weeks post-dose. * The total score ranges from 0 to 144 and the higher the score, the more neuropsychiatric symptoms.
Time frame: At 8 weeks and 12 weeks post-dose
Number of participants with adverse events, with abnormal physical exam findings and abnormal laboratory tests results.
\- To compare the safety of dose groups and active comparator group based on adverse events and clinical laboratory tests at 12 weeks post-dose.
Time frame: At 12 weeks post-dose