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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
390
Sustained-Release Tablet, 400µg once a day, 24 weeks
Tablet, 200µg twice a day, 24 weeks
placebo orally twice a day
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
RECRUITINGAlzheimer'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
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