RecruitingPhase 2Phase 3NCT07066826

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


Sponsor

Wanbangde Pharmaceutical Group Co., LTD

Enrollment

720 participants

Start Date

Aug 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Donepezil hydrochloride tablets, a drug called Huperzine A Controlled-Release Tablets, and others for people with alzheimer dementia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHuperzine A Controlled-Release Tablets

During the trial, the patients should take huperzine A controlled-release tablets in the morning

DRUGDonepezil hydrochloride tablets

During the trial, the patients should take donepezil hydrochloride tablets before going to bed in the evening

DRUGHuperzine 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


Locations(1)

Xuanwu Hospital Capital Medical University

Beijing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07066826


Related Trials