Clinical Trial Details

NCT ID: NCT01282619
Date Last Changed: January 24, 2011


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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Recruitment Details

Both Male and Female
50 to 85 Years
Overall Status
Lead Sponsor
Shandong Luye Pharmaceutical Co., Ltd.
25 Months
Facility Type


Both Male and Female ages 50 Years to 85 Years

Inclusion Criteria:

  1. Male/female patient aged between 50 and 85

  2. Clinical diagnosis of mild to moderate probable AD based on DSM-IV and the NINCDS-ADRDA criteria

  3. Middle school or above: 11 ≤MMSE ≤ 24, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16;

  4. CT or MRI scan excluding another structural brain disease;

  5. Hachinski Ischemic Score < 4

  6. Hamilton Depression Scale ≤10

  7. Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.

Exclusion Criteria:

  1. Proven or clinically suspected other type of dementia such as vascular dementia, mechanic or chemical caused dementia, vitamin B12 deficiency, hypothyroidism etc.

  2. Epileptic Patient

  3. Severe liver or renal disease

  4. Resting pulse less than 50

  5. Mechanical intestinal obstruction patient

  6. History of stroke

  7. History of angina or other severe cardiac, vascular, lung, gastrointestinal and hematopoietic system disease

  8. Cognitive damage caused by alcohol or substance abuse

  9. Disable to participate or cooperate in the protocol

  10. Use of any agent for the treatment of dementia within 2 weeks of randomization

  11. Use of another investigational agent within 3 months of screening

  12. Be sensitive to Huperzine A or other ACHEIs.

Site Locations (1)

Country State City Zip Facility and Contact
China Shanghai Shanghai 200000 Shanghai Mental Health Center

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