Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05811000
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-03-17
Brief Title:
A Phase 2 Clinical Study to Explore the Optimal DosageAdministration of PM012 Tablet in Alzheimers Disease
Sponsor:
Mediforum Ltd Co
Organization:
Mediforum Ltd Co
Study Overview
Official Title:
A Phase 2 Clinical Study to Explore the Optimal DosageAdministration of PM012 Tablet in Alzheimers Disease Double-Blind Randomized Between Placebo Control Group and Dose Groups Parallel-Design Multicenter Study
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PM012-2b
Brief Summary:
To evaluate the safety and efficacy of PM012 tablets for Alzheimers 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 products 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 Alzheimers disease by comparing the safety and efficacy of the investigational product PM012 tablet administered to the 2600 mg day group 3900 mg day group and 5200 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None