NCT07066826

Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel-Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Wanbangde Pharmaceutical Group Co., LTD · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group clinical trial. The dose confirmation stage is designed to evaluate the efficacy and safety of different doses of huperzine A controlled-release tablets in patients with mild-to-moderate dementia of the Alzheimer's type, with the goal of providing a basis for dose selection in the subsequent efficacy confirmation stage. The efficacy confirmation stage aims to assess the effect of huperzine A controlled-release tablets on cognitive function and functional abilities in patients with mild-to-moderate dementia of the Alzheimer's type.In the open-label extension stage, all subjects will receive huperzine A controlled-release tablets until Week 52, to further evaluate the long-term efficacy and safety of the treatment.

Conditions

• Alzheimer Dementia

Interventions

Type	Name	Description
DRUG	Huperzine A Controlled-Release Tablets	During the trial, the patients should take huperzine A controlled-release tablets in the morning
DRUG	Donepezil hydrochloride tablets	During the trial, the patients should take donepezil hydrochloride tablets before going to bed in the evening
DRUG	Huperzine A controlled-release tablets placebo; Donepezil hydrochloride tablets placebo	During the trial, the patients should take huperzine A controlled-release tablets placebo in the morning and donepezil hydrochloride tablets placebo before going to bed in the evening

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-08-15
• Completion: 2028-08-15
• First posted: 2025-07-15
• Last updated: 2025-07-15