NCT05811000

A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Mediforum Ltd., Co. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Mild Alzheimer Disease

Interventions

Type	Name	Description
DRUG	PM012	PM012 650 mg tablet drug
DRUG	PM012 Placebo	PM012 tablet placebo
DRUG	Donepezil	Aricept 5 mg (donepezil hydrochloride) drug
DRUG	Donepezil placebo	Aricept 5 mg (donepezil hydrochloride) placebo

Timeline

• Start date: 2020-11-27
• Primary completion: 2021-02-24
• Completion: 2024-08-13
• First posted: 2023-04-13
• Last updated: 2023-04-18

Locations

1 site across 1 country: South Korea