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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01282619
Recruitment Status : Unknown
Verified January 2011 by Shandong Luye Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : January 25, 2011
Last Update Posted : January 25, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Huperzine A Drug: huperzine A Drug: Placebo Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : May 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Huperzine A Sustained-Release Tablet Drug: Huperzine A
Sustained-Release Tablet, 400µg once a day, 24 weeks

Active Comparator: Huperzine A Tablet Drug: huperzine A
Tablet, 200µg twice a day, 24 weeks

Placebo Comparator: Placebo Drug: Placebo
placebo orally twice a day

Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. Clinician's Interview Based Impression of Change, plus caregiver input [ Time Frame: week 24 ]
  2. Activities of Daily Living [ Time Frame: week 24 ]
  3. Neuropsychiatric Inventory [ Time Frame: week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01282619

China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200000
Contact: Wang    861085865101      
Sponsors and Collaborators
Shandong Luye Pharmaceutical Co., Ltd.

Responsible Party: Department of Medical Affairs, Shandong Luye Pharmaceutical Co., Identifier: NCT01282619     History of Changes
Other Study ID Numbers: LY200901-04
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Huperzine A
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents