Mild Alzheimer Disease Clinical Trial
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
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. ;