Huperzine A in Alzheimer's Disease

Completed · Phase 2

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT00083590

Run by

National Institute on Aging (NIA)

People needed

150

Starts

2004-04-01

Expected to finish

2007-11-01

Last updated by the study team

2008-02-21

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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).
• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• University of California, San Diego, Alzheimer's Disease Research Center — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, Davis — Sacramento, California, United States
• Georgetown University Medical Center, Memory Disorders Program — Washington D.C., District of Columbia, United States
• Howard University School of Medicine — Washington D.C., District of Columbia, United States
• MD Clinical — Fort Lauderdale, Florida, United States
• Roskamp Institute Memory Clinic — Tampa, Florida, United States
• University of South Florida, Suncoast Alzheimer's and Gerontology Center — Tampa, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush Alzheimer's Disease Center, Rush University Medical Center — Chicago, Illinois, United States
• ICPS Group — Boston, Massachusetts, United States
• University of Nevada School of Medicine — Las Vegas, Nevada, United States
• Alzheimer's Research Corporation — Paterson, New Jersey, United States
• University of Medicine and Dentistry of New Jersey — Piscataway, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• New York University Medical Center — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Nathan S. Kline Institute for Psychiatric Research — Orangeburg, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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