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Abstract
Objective: 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).
Methods: 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 at least 16 weeks, with 177 subjects completing the treatment phase. The primary analysis assessed the cognitive effects of huperzine A 200 μg BID (change in Alzheimer's Disease Assessment Scale–cognitive subscale [ADAS-Cog] at week 16 at 200 μg BID compared to placebo). Secondary analyses assessed the effect of huperzine A 400 μg 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).
Results: Huperzine A 200 μg BID did not influence change in ADAS-Cog at 16 weeks. In secondary analyses, huperzine A 400 μg 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.
Conclusion: The primary efficacy analysis did not show cognitive benefit with huperzine A 200 μg BID.
Classification of evidence: This study provides Class III evidence that huperzine A 200 μg BID has no demonstrable cognitive effect in patients with mild to moderate AD.
Footnotes
-
Study funding: Supported by the NIH/NIA and Neuro-Hitech, Inc. The manuscript was shared with representatives of NIA.
-
- AChE=
- acetylcholinesterase;
- AD=
- Alzheimer disease;
- ADAS-Cog=
- Alzheimer's Disease Assessment Scale–cognitive subscale;
- ADCS-ADL=
- Alzheimer's Disease Cooperative Study Activities of Daily Living scale;
- ADCS-CGIC=
- Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change;
- AE=
- adverse effect;
- ANCOVA=
- analysis of covariance;
- APP=
- amyloid precursor protein;
- LOCF=
- last observation carried forward;
- MMSE=
- Mini-Mental State Examination;
- NPI=
- Neuropsychiatric Inventory;
- SAE=
- serious adverse effect.
-
Supplemental data at www.neurology.org
- Received May 12, 2010.
- Accepted January 10, 2011.
- Copyright © 2011 by AAN Enterprises, Inc.
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