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

January 24, 2011
January 24, 2011
May 2010
June 2012   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Huperzine A Sustained-Release Tablets in Patients With Alzheimer's Disease
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

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Alzheimer's Disease
  • Drug: Huperzine A
    Sustained-Release Tablet, 400µg once a day, 24 weeks
  • Drug: huperzine A
    Tablet, 200µg twice a day, 24 weeks
  • Drug: Placebo
    placebo orally twice a day
  • Experimental: Huperzine A Sustained-Release Tablet
    Intervention: Drug: Huperzine A
  • Active Comparator: Huperzine A Tablet
    Intervention: Drug: huperzine A
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
390
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
China
 
NCT01282619
LY200901-04
Yes
Department of Medical Affairs, Shandong Luye Pharmaceutical Co.,
Shandong Luye Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Shandong Luye Pharmaceutical Co., Ltd.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP