This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.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.To test the hypothesis that huperzine A is useful in the treatment of individuals with AD, we will conduct a multicenter, double-blind, placebo-controlled therapeutic trial to determine whether natural huperzine A improves cognitive function. This is a Phase II study; the outcome of the study is not likely to contribute to a change in standard care, but rather will determine whether a larger, definitive study should be initiated. A total of 150 participants will be randomly assigned to three equal groups, allowing comparison of huperzine A 200 g bid, huperzine A 400 g bid and placebo. The primary outcome measure will be the change in score on the Alzheimer's Disease Assessment Scale (ADAScog) at the 16 week visit. Secondary outcome measures include the ADCS clinical global impression of change (CGIC) (Schneider et al 1997) and activities of daily living (ADL) (Galasko et al 1997) scales, and the Neuropsychiatric Inventory (Cummings 1997).
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