Huperzine A in Alzheimer's Disease
A Multi-Center, Double-Blind, Placebo-Controlled Therapeutic Trial to Determine Whether Natural Huperzine A Improves Cognitive Function
3 other identifiers
interventional
150
1 country
29
Brief Summary
The present study will evaluate the safety and efficacy of the Chinese herb huperzine A in the treatment of Alzheimer's disease (AD) in a randomized controlled trial of its effect on cognitive function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 alzheimer-disease
Started Apr 2004
Typical duration for phase_2 alzheimer-disease
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 26, 2004
CompletedFirst Posted
Study publicly available on registry
May 27, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFebruary 21, 2008
February 1, 2008
3.6 years
May 26, 2004
February 19, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- NINDS/ADRDA criteria for probable AD.
- Mini Mental State Examination between 10 and 24, inclusive.
- Stable medical condition for 3 months prior to screening.
- Supervision available for administration of study medications.
- Study partner to accompany participant to all scheduled visits.
- Fluent in English or Spanish.
- Age 55 years or older.
- Modified Hachinski score equal to or less than 4.
- CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion.
- Able to complete baseline assessments.
- years of education, or work history sufficient to exclude mental retardation.
- Able to ingest oral medication.
- Stable doses of medications for 4 weeks prior to screening.
- Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
You may not qualify if:
- History of active peptic ulcer disease within 1 year of screening.
- Clinically significant cardiac arrhythmia.
- Resting pulse less than 50.
- Active neoplastic (cancer) disease (skin tumors other than melanoma are not excluded; participants with stable prostate cancer may be included at the discretion of the Project Director).
- Use of another investigational agent within 2 months of screening.
- History of clinically significant stroke.
- Current evidence or history in the past 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injury, or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
- Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol.
- Residence in a skilled nursing facility; but patients in an assisted living facility are acceptable.
- Excluded Medications:
- Use of cholinesterase inhibitors (galantamine, rivastigmine, donepezil, and tacrine) within 2 months of screening.
- Regular use of narcotic analgesics (\>2 doses per week) within 4 weeks of screening.
- Use of medications with significant central nervous system anticholinergic activity within 2 months of screening (e.g. tricyclic antidepressants, diphenhydramine).
- Use of anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegiline) within 2 months of screening.
- Participation in any other investigational drug study within 2 months of screening (individuals may not participate in any other drug study while participating in this protocol).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Aging (NIA)lead
- Alzheimer's Disease Cooperative Study (ADCS)collaborator
- Neuro-Hitechcollaborator
Study Sites (29)
University of Alabama
Birmingham, Alabama, 35294, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
University of California, Irvine
Irvine, California, 92697, United States
University of California, San Diego, Alzheimer's Disease Research Center
La Jolla, California, 92037, United States
University of Southern California
Los Angeles, California, 90033, United States
University of California, Davis
Sacramento, California, 95817, United States
Georgetown University Medical Center, Memory Disorders Program
Washington D.C., District of Columbia, 20057, United States
Howard University School of Medicine
Washington D.C., District of Columbia, 20060, United States
MD Clinical
Fort Lauderdale, Florida, 33321, United States
Roskamp Institute Memory Clinic
Tampa, Florida, 33617, United States
University of South Florida, Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, 33617, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Emory University
Atlanta, Georgia, 30329, United States
Rush Alzheimer's Disease Center, Rush University Medical Center
Chicago, Illinois, 60612, United States
ICPS Group
Boston, Massachusetts, 02131, United States
University of Nevada School of Medicine
Las Vegas, Nevada, 89102, United States
Alzheimer's Research Corporation
Paterson, New Jersey, 08759, United States
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, 08855, United States
Albany Medical Center
Albany, New York, 12208, United States
New York University Medical Center
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, 10962, United States
University of Rochester Medical Center
Rochester, New York, 14620, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Oregon Health and Science University
Portland, Oregon, 97201, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
North Charleston, South Carolina, 29406, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Vermont College of Medicine
Burlington, Vermont, 05401, United States
Related Publications (3)
Bai DL, Tang XC, He XC. Huperzine A, a potential therapeutic agent for treatment of Alzheimer's disease. Curr Med Chem. 2000 Mar;7(3):355-74. doi: 10.2174/0929867003375281.
PMID: 10637369BACKGROUNDVed HS, Koenig ML, Dave JR, Doctor BP. Huperzine A, a potential therapeutic agent for dementia, reduces neuronal cell death caused by glutamate. Neuroreport. 1997 Mar 3;8(4):963-8. doi: 10.1097/00001756-199703030-00029.
PMID: 9141073BACKGROUNDMazurek A: An open-label trial of huperzine A in the treatment of Alzheimer's disease. Alternative Therapies 5(2): 97-98, March 16, 2000.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul S. Aisen, MD
Georgetown University Medical Center, Memory Disorders Program
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
May 26, 2004
First Posted
May 27, 2004
Study Start
April 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
February 21, 2008
Record last verified: 2008-02