Huperzine A study
Introduction
The Huperzine A Study, a 6-month clinical trial to find out whether natural huperzine A treats the symptoms of AD, is open for recruitment & has been added to the Alzheimer's Disease Education & Referral Center's Clinical Trials Database[4], a service of the National Institute on Aging (NIA). This study is being conducted at 23 sites around the country, led by Georgetown University, supported by the Alzheimer's Disease Cooperative Study at UC San Diego, & funded by NIA.
Researchers for this study are seeking participants who:
- have been diagnosed with mild to moderate AD
- are age 55 or older
- are NOT currently taking cholinesterase inhibitors (such as Aricept, Exelon, or Reminyl)
- speak English or Spanish
- have a friend or relative who can accompany the volunteer to all clinic visits & answer questions about him or her
The full record for the study, including study sites & specific eligibility criteria, is attached below.
To view this and other AD research studies on our Web site, go to ref[1] - click on 'View All Trials' and select the trial you would like to view.
For questions, call us toll-free at 1-800-438-4380 (Monday-Friday, 8:30am-5pm Eastern Time).
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Protocol Number: IA0052
Protocol Title: Huperzine A in Alzheimer's Disease
Official Title
A Multi-Center, Double-Blind, Placebo-Controlled Therapeutic Trial to Determine Whether Natural Huperzine A Improves Cognitive Function
Sponsoring Agency: National Institute on Aging (NIA)
Principal Investigator:
Paul Aisen, MD, Georgetown University Medical Center, Department of Neurology, One Bles Building, 3800 Reservoir Road, N.W. Washington, DC, District of Columbia, 20007
Contact Person: Sally P. Walsh, MB, MRCPsycg Tel: 202-687-8323
E-mail: spw9@georgetown.edu
Drug(s) (Generic Name [Brand Name]): Huperzine A
Phase: Phase II
Summary: The present study will evaluate the safety & 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.
Detailed Description: Huperzine A is a natural cholinesterase inhibitor derived from the Chinese herb Huperzia serrata. There is evidence that huperzine A may compare favorably in symptomatic efficacy to cholinesterase inhibitors currently in use. In addition, huperzine A has antioxidant & neuroprotective properties that suggest that it may be useful as a disease-modifying treatment for Alzheimer's disease (AD). The drug is currently available as a nutraceutical in this country, & is being used by some U.S. clinicians to treat AD. However, there have been no controlled clinical trials outside China assessing its toxicity & efficacy. The present study will evaluate huperzine A in the treatment of AD in a randomized controlled trial of its effect on cognitive function.
The primary aim of this multicenter, double-blind, placebo-controlled therapeutic Phase II trial is to determine whether treatment with huperzine A 200 ug twice a day improves cognitive function in individuals with AD.
Secondary aims of this study are to: a) determine whether treatment with huperzine A 400 ug twice a day improves cognitive function in individuals with AD; b) determine the effect of huperzine A treatment on global clinical status, activities of daily living, and behavior in AD;
- evaluate the tolerability of huperzine A treatment at dosages of 200 ug twice a day and 400 ug twice a day in AD; & d) determine the relationship between blood cholinesterase activity and cognitive function in individuals with AD treated with huperzine A.
A total of 150 participants will be randomly assigned to three groups of equal size. This will allow a comparison of huperzine A 200 ug twice a day, huperzine A 400 ug twice a day, & placebo. The primary outcome measures will be the change in score on the ADAScog at the 16 week visit. Secondary outcome measures include the ADCS clinical global impression of change (CGIC) (Schneider et al 1997) & activities of daily living (ADL) (Galasko et al 1997) scales, & the Neuropsychiatric Inventory (Cummings 1997). Volunteers must be able to participate in the study for 24 weeks & make 9 visits to the trial site.
Inclusion Criteria:
- NINDS/ADRDA criteria for probable AD.
- Mini Mental State Examination between 10 & 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 greater than 4.
- CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion.
- Able to complete baseline assessments.
- 6 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.
Exclusion Criteria:
- 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.
Prohibited 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, selegeline) 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).
- Use of estrogen is allowed if the dose has been stable for 3 months prior to screening.
- Use of vitamin E is allowed if the dose has been stable for 3 months prior to screening.
- Use of memantine is allowed if the dose has been stable for 3 months prior to screening.
Precautions:
There have been 6 reported trials of Huperzine A treatment for AD in China with no serious adverse effects reported. Minor gastrointestinal effects, particularly nausea, are common, presumably related to peripheral anticholinergic activity.
Trial Sites:
*Alabama*
University of Alabama, Birmingham, Alabama, 35294, United States; Not yet recruiting
*California*
University of California, Irvine, Irvine, California, 92697, United States; Recruiting
Contact: Catherine McAdams-Ortiz, RN 949-824-8726 cmcadams@uci.edu
University of California, Davis, Sacramento, California, 95817, United States; Not yet recruiting
University of Southern California, Los Angeles, California, 90033, United States; Not yet recruiting
University of California, San Diego, Alzheimer's Disease Research Center, La Jolla, California, 92037, United States; Recruiting
Contact: Karen Wetzel 858-622-5800 kwetzel@ucsd.edu
University of California, San Francisco, California, 94143, United States; Not yet recruiting
*District of Columbia*
Georgetown University Medical Center, Memory Disorders Program, Washington, District of Columbia, 20057, United States; Recruiting
Contact: Sally P. Walsh, MB, MRCPsycg 202-687-8323 spw9@georgetown.edu
Howard University School of Medicine, Washington, DC, District of Columbia, 20060, United States; Not yet recruiting
*Florida*
Premiere Research Institute, West Palm Beach, Florida, 33407, United States; Recruiting
Contact: Cora Kessel 561-845-0500 Ext. 136 eneuro@aol.com
Baumel-Eisner Neuromedical Institute, Fort Lauderdale, Florida, 33321, United States; Recruiting
Contact: Marina Rieken, LPN 954-720-1899 mrieken@advancepcs.com
University of South Florida, Tampa, Florida, 33617, United States; Recruiting
Contact: Amanda Smith, MD 813-976-4355 asmith2@hsc.usf.edu *Georgia*
Emory University, Atlanta, Georgia, 30329, United States; Recruiting Contact: Jane Lu, BA 404-728-4784 cjlu@emory.edu
*Illinois*
Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois, 60612, United States; Recruiting
Contact: Julie Bach, MSW, MSG 312-942-8264 jbach@rush.edu
*Nevada*
University of Nevada School of Medicine, Las Vegas, Nevada, 89102, United States; Not yet recruiting
*New Jersey*
University of Medicine and Dentistry of New Jersey, Piscataway, New Jersey, 08855, United States; Recruiting
Contact: Julie Coleman, RN, BSN 732-235-4907 colemanjs@cmhc.umdnj.edu
*New York*
University of Rochester Medical Center, Rochester, New York, 14620, United States; Recruiting
Contact: Linda Terwilliger, BSN 585-760-6565 Linda_Terwilliger@URMC.rochester.edu
New York University Medical Center, New York, New York, 10016, United States; Recruiting
Contact: Suzanne Blaisdell, MA 212-263-5708 suzanne.blaisdell@med.nyu.edu
Mount Sinai School of Medicine, New York, New York, 10029, United States; Recruiting
Contact: Edwin Canas 212-241-1514 edwin.canas@mssm.edu
*North Carolina*
University of North Carolina, Chapel Hill, North Carolina, 27599, United States; Not yet recruiting
*Oregon*
Oregon Health and Science University, Portland, Oregon, 97201, United States; Not yet recruiting
*Pennsylvania*
University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Not yet recruiting
*South Carolina*
Medical University of South Carolina, North Charleston, South Carolina, 29406, United States; Recruiting
Contact: Don Bagwell 843-740-1592 Ext. 29 bagwelld@musc.edu
*Texas*
University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States; Recruiting
Contact: Kathleen Koch, MN, RN 214-648-7462 kathleen.rice-koch@utsouthwestern.edu
More general terms
Additional terms
References
- ↑ 1.0 1.1 Alzheimers.org trials http://www.alzheimers.org/trials/basicsearch.html
- ↑ Bai DL et al Huperzine A, A Potential Therapeutic Agent for Treatment of Alzheimer's Disease. Current Medical Chemistry 7(3): 355-274. March 2000. PMID: https://www.ncbi.nlm.nih.gov/pubmed/10637369
- ↑ Ved HS et al Huperzine A, A Potential Therapeutic Agent for Dementia, Reduces Neuronal Cell Death Caused by Glutamate Neuroreport 8:963-8. March 1997 PMID: https://www.ncbi.nlm.nih.gov/pubmed/9141073
- ↑ 4.0 4.1 Alzheimer's Disease Education & Referral Center's Clinical Trials Database http://www.alzheimers.org/trials/index.html