drugset / Trial / NCT05811000

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

NCT05811000

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Donepezil Small molecule 5 mg Oral
Subject PM012 Unknown 2600 mg Oral
Subject PM012 Unknown 3900 mg Oral
Subject PM012 Unknown 5200 mg Oral

Indications