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A phase II trial of huperzine A in mild to moderate Alzheimer disease.


ABSTRACT: Huperzine A is a natural cholinesterase inhibitor derived from the Chinese herb Huperzia serrata that may compare favorably in symptomatic efficacy to cholinesterase inhibitors currently in use for Alzheimer disease (AD).We assessed the safety, tolerability, and efficacy of huperzine A in mild to moderate AD in a multicenter trial in which 210 individuals were randomized to receive placebo (n = 70) or huperzine A (200 ?g BID [n = 70] or 400 ?g BID [n = 70]), for at least 16 weeks, with 177 subjects completing the treatment phase. The primary analysis assessed the cognitive effects of huperzine A 200 ?g BID (change in Alzheimer's Disease Assessment Scale-cognitive subscale [ADAS-Cog] at week 16 at 200 ?g BID compared to placebo). Secondary analyses assessed the effect of huperzine A 400 ?g BID, as well as effect on other outcomes including Mini-Mental State Examination, Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change scale, Alzheimer's Disease Cooperative Study Activities of Daily Living scale, and Neuropsychiatric Inventory (NPI).Huperzine A 200 ?g BID did not influence change in ADAS-Cog at 16 weeks. In secondary analyses, huperzine A 400 ?g BID showed a 2.27-point improvement in ADAS-Cog at 11 weeks vs 0.29-point decline in the placebo group (p = 0.001), and a 1.92-point improvement vs 0.34-point improvement in the placebo arm (p = 0.07) at week 16. Changes in clinical global impression of change, NPI, and activities of daily living were not significant at either dose.The primary efficacy analysis did not show cognitive benefit with huperzine A 200 ?g BID.This study provides Class III evidence that huperzine A 200 ?g BID has no demonstrable cognitive effect in patients with mild to moderate AD.

SUBMITTER: Rafii MS 

PROVIDER: S-EPMC3269774 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature

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A phase II trial of huperzine A in mild to moderate Alzheimer disease.

Rafii M S MS   Walsh S S   Little J T JT   Behan K K   Reynolds B B   Ward C C   Jin S S   Thomas R R   Aisen P S PS  

Neurology 20110401 16


<h4>Objective</h4>Huperzine A is a natural cholinesterase inhibitor derived from the Chinese herb Huperzia serrata that may compare favorably in symptomatic efficacy to cholinesterase inhibitors currently in use for Alzheimer disease (AD).<h4>Methods</h4>We assessed the safety, tolerability, and efficacy of huperzine A in mild to moderate AD in a multicenter trial in which 210 individuals were randomized to receive placebo (n = 70) or huperzine A (200 μg BID [n = 70] or 400 μg BID [n = 70]), for  ...[more]

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