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

• Status: Unknown status
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Luye Pharmaceutical Co., Ltd.
• Treatments: Huperzine A

Criteria

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.