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HUPERZINE

Background and Significance
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 and 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 nutriceutical in this country, and is being used by some U.S. clinicians to treat AD. However, there have been no controlled clinical trials outside China assessing its toxicity and efficacy. The present study will evaluate huperzine A in the treatment of AD in a randomized controlled trial of its effect on cognitive function.

What is the main objective of this study?
The main objective of this study is to determine whether treatment with huperzine A (200 µg twice a day) improves cognitive function in patients with Alzheimer's disease.

What are the secondary objectives of this study?
The other objectives of this study are:
  • To determine whether treatment with a higher dose of huperzine A (400 µg twice a day) improves cognitive function in patients with AD.
  • To determine the effect of huperzine A treatment on global clinical status, activities of daily living, and behavior in AD.
  • To evaluate the tolerability of huperzine A treatment at dosages of 200 µg twice a day and 400 µg twice a day in AD.
  • To determine the relationship between blood cholinesterase activity and cognitive function in AD patients treated with huperzine A.

How will the study be conducted?
This Phase II study is a multicenter, double-blind, placebo-controlled therapeutic trial.

How many patients will be participating in the study?
A total of 150 patients will be recruited for the study with 15 patients from USC.

How will the study be conducted?
This study utilizes a 3-arm randomized placebo-controlled parallel design. Participants will be randomly assigned to three equal groups- huperzine A 200µg bid, huperzine A 400µg bid and placebo.

Who is eligible to participate in this study?
The following are the eligibility criteria for this study:
  • NINCDS/ADRDA criteria for probable AD
  • MMSE between 10 and 24, inclusive
  • stable medical condition for 3 months prior to screening
  • study partner to accompany participant to all scheduled visits
  • fluent in English or Spanish
  • age > 55
  • modified Hachinski < 4
  • CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion
  • stable dose of medications for 4 weeks prior to screening

How can I enroll in this study?
This study is currently enrolling volunteers. If interested, please contact:
Maya Slowinska
USC/Geriatric Studies Center
(323) 442-7600
E-mail: mslowins@usc.edu



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