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

NCT ID: NCT01282619

Last Updated: 2011-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-06-30

Brief 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.

Detailed 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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Huperzine A Sustained-Release Tablet

Group Type: EXPERIMENTAL

Huperzine A

Intervention Type: DRUG

Sustained-Release Tablet, 400µg once a day, 24 weeks

Huperzine A Tablet

Group Type: ACTIVE_COMPARATOR

huperzine A

Intervention Type: DRUG

Tablet, 200µg twice a day, 24 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo orally twice a day

Interventions

Huperzine A

Sustained-Release Tablet, 400µg once a day, 24 weeks

Intervention Type: DRUG

huperzine A

Tablet, 200µg twice a day, 24 weeks

Intervention Type: DRUG

Placebo

placebo orally twice a day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Luye Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Shandong Luye Pharmaceutical Co.,

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wang

Role: primary

861085865101

Other Identifiers

LY200901-04

Identifier Type: -

Identifier Source: org_study_id