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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01282619
• Other study ID #: LY200901-04
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 24, 2011
• Last updated: January 24, 2011
• Start date: May 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2011
• Source: Shandong Luye Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Huperzine A
Sustained-Release Tablet, 400µg once a day, 24 weeks
• huperzine A
Tablet, 200µg twice a day, 24 weeks
• Placebo
placebo orally twice a day

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Luye Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale - Cognitive Subscale		week 24	No
Secondary	Clinician's Interview Based Impression of Change, plus caregiver input		week 24	No
Secondary	Activities of Daily Living		week 24	No
Secondary	Neuropsychiatric Inventory		week 24	No