Study of Huperzine A Sustained-Release Tablets in Patients With Alzheimer's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01282619|
Recruitment Status : Unknown
Verified January 2011 by Shandong Luye Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted : January 25, 2011
Last Update Posted : January 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Huperzine A Drug: huperzine A Drug: Placebo||Phase 2 Phase 3|
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:
- A two-week placebo run-in period
- A 6-month double blind treatment period, consisting of three months of titration and three months of fixed dose treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
|Experimental: Huperzine A Sustained-Release Tablet||
Drug: Huperzine A
Sustained-Release Tablet, 400µg once a day, 24 weeks
|Active Comparator: Huperzine A Tablet||
Drug: huperzine A
Tablet, 200µg twice a day, 24 weeks
|Placebo Comparator: Placebo||
placebo orally twice a day
- Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: week 24 ]
- Clinician's Interview Based Impression of Change, plus caregiver input [ Time Frame: week 24 ]
- Activities of Daily Living [ Time Frame: week 24 ]
- Neuropsychiatric Inventory [ Time Frame: week 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282619
|Shanghai Mental Health Center||Recruiting|
|Shanghai, Shanghai, China, 200000|
|Contact: Wang 861085865101|