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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Shandong Luye Pharmaceutical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shandong Luye Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01282619
First received: January 24, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Huperzine A
Drug: huperzine A
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Shandong Luye Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician's Interview Based Impression of Change, plus caregiver input [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Activities of Daily Living [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: May 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282619

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

No publications provided

Responsible Party: Department of Medical Affairs, Shandong Luye Pharmaceutical Co.,
ClinicalTrials.gov Identifier: NCT01282619     History of Changes
Other Study ID Numbers: LY200901-04
Study First Received: January 24, 2011
Last Updated: January 24, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Huperzine A
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014