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Clinical Trial Details
Research Study Summary
A clinical research study of Huperzine A, huperzine A and Placebo for the treatment of Alzheimer's Disease
Research Study 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
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.
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Both Male and Female
Both Male and Female ages 50 Years to 85 Years
Male/female patient aged between 50 and 85
Clinical diagnosis of mild to moderate probable AD based on DSM-IV and the
Middle school or above: 11 ≤MMSE ≤ 24, elementary school: 8 ≤ MMSE ≤ 20, illiteracy:
5 ≤ MMSE ≤ 16;
CT or MRI scan excluding another structural brain disease;
Hachinski Ischemic Score < 4
Hamilton Depression Scale ≤10
Informed consent of the patient (or legal representative) and of the caregiver
agreeing to take part in the study.
Proven or clinically suspected other type of dementia such as vascular dementia,
mechanic or chemical caused dementia, vitamin B12 deficiency, hypothyroidism etc.
Severe liver or renal disease
Resting pulse less than 50
Mechanical intestinal obstruction patient
History of stroke
History of angina or other severe cardiac, vascular, lung, gastrointestinal and
hematopoietic system disease
Cognitive damage caused by alcohol or substance abuse
Disable to participate or cooperate in the protocol
Use of any agent for the treatment of dementia within 2 weeks of randomization
Use of another investigational agent within 3 months of screening
Be sensitive to Huperzine A or other ACHEIs.
Site Locations (1)
||Shanghai Mental Health Center
NCT ID: NCT01282619
Date Last Changed: January 24, 2011
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