NCT01282619

Study of Huperzine A Sustained-Release Tablets in Patients With Alzheimer's Disease

A Multi-Center, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Study to Evaluate the Safety and Efficacy of Huperzine A Sustained-Release Tablets in Patients With Mild to Moderate Alzheimer's Disease

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Shandong Luye Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety and efficacy of Huperzine A sustained release tablets in patients with mild to moderate Alzheimer's Disease.

Detailed description

The primary aim of this multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled therapeutic trial is to determine whether treatment with huperzine A sustained-release tablets can improve cognitive function in individuals with AD. A total of 390 participants will be randomly assigned to three groups of equal size. This will allow a comparison of huperzine A sustained-release tablets 400µg once a day, huperzine A tablets 200µg twice a day, and placebo. The study is divided into 2 periods: 1. A two-week placebo run-in period 2. A 6-month double blind treatment period, consisting of three months of titration and three months of fixed dose treatment.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Huperzine A	Sustained-Release Tablet, 400µg once a day, 24 weeks
DRUG	huperzine A	Tablet, 200µg twice a day, 24 weeks
DRUG	Placebo	placebo orally twice a day

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-01-25
• Last updated: 2011-01-25

Locations

1 site across 1 country: China