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

NCT05811000 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2023-04-18

No results posted yet for this study

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

Conditions

  • Mild Alzheimer Disease

Interventions

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

Sponsors & Collaborators

  • LSK Global Pharma Services Co. Ltd.

    collaborator UNKNOWN

  • Mediforum Ltd., Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-27
Primary Completion
2021-02-24
Completion
2024-08-13

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05811000 on ClinicalTrials.gov