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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

NCT07066826 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2025-07-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Wanbangde Pharmaceutical Group Co., LTD

    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
2025-08-01
Primary Completion
2028-08-15
Completion
2028-08-15

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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 NCT07066826 on ClinicalTrials.gov