drugset / Trial / NCT05811000
A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |