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

Phase 2

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: huperzine A

• Registration Number: NCT01282619
• Lead Sponsor: Shandong Luye Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2010-05
• Status Verified: 2011-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Last Update Submitted: 2011-01-24
• Study First Posted: 2011-01-25
• Last Update Posted: 2011-01-25
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Huperzine A Sustained-Release Tablet	huperzine A	-
Huperzine A Tablet	huperzine A	-

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale - Cognitive Subscale	week 24

Secondary Outcome Measures

Name	Time	Method
Clinician's Interview Based Impression of Change, plus caregiver input	week 24
Activities of Daily Living	week 24
Neuropsychiatric Inventory	week 24

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China