Status:
COMPLETED
Huperzine A in Alzheimer's Disease
Lead Sponsor:
National Institute on Aging (NIA)
Collaborating Sponsors:
Alzheimer's Disease Cooperative Study (ADCS)
Neuro-Hitech
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE2
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 functio...
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 inh...
Eligibility Criteria
Inclusion
- The selection process is designed to allow enrollment of all people with AD who are likely to be testable at the conclusion of the study period, and who do not have concurrent medical conditions or medications that might influence cognitive testing or that would increase the risk of treatment. Women and members of minority groups are encouraged to volunteer.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00083590
Start Date
April 1 2004
End Date
November 1 2007
Last Update
February 21 2008
Active Locations (29)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
3
University of California, Irvine
Irvine, California, United States, 92697
4
University of California, San Diego, Alzheimer's Disease Research Center
La Jolla, California, United States, 92037