Huperzine A in mild to moderate Alzheimer's 
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Neuro-Hitech, Inc. (NASDAQ: NHPI), a New York-based biopharmaceutical company focused on developing innovative drugs for the treatment of neurodegenerative diseases, announced top-line results from the double-blind part of a phase 2 clinical trial of Huperzine A in mild to moderate Alzheimer's disease (AD) patients. Huperzine A is a naturally occurring alkaloid compound derived from the club moss Huperzia serrata. Huperzine A is a highly potent and selective reversible inhibitor of acetylcholinesterase. In addition, Huperzine A possesses neuroprotective properties against glutamate induced neuronal toxicity at the NMDA receptor and has antioxidative properties. Furthermore, Huperzine A reduces the neurotoxic effects of B-amyloid and diminishes B-amyloid generation. In addition to the oral formulation currently being clinically studied, NHPI is also developing the drug in a transdermal patch.
The phase 2 clinical trial was conducted in the United States in collaboration with the National Institute on Aging and the Alzheimer's Disease Cooperative Study Group (ADCS). The study is a multi-center, randomized, double-blind, placebo-controlled trial in 210 patients with mild to moderate Alzheimer's disease. The trial compared the safety, tolerability and efficacy of either 200 or 400 micrograms of Huperzine A administered orally twice a day for 16 weeks versus placebo. The study measured the efficacy of Huperzine A on cognitive function, activities of daily living and behavior. Of the 210 patients enrolled in this study approximately half received concomitant treatment with Namenda® an FDA approved drug for Alzheimer's disease.
Results showed that there was no statistical difference in the mean change on AD Assessment Scale- Cognitive (ADAS-Cog) scores, the primary endpoint, after 16 weeks treatment with Huperzine A 200 micrograms bid compared to placebo (p=0.81). However, data demonstrated that the higher dose tested, 400 micrograms bid, showed cognitive enhancement on the ADAS-Cog versus placebo. The maximum cognitive improvement was observed at week 11 of treatment (p=0.001). Over 16 weeks Huperzine A (400 micrograms bid) improved cognition compared to placebo (p=0.03) and there was a trend to cognitive improvement over placebo at week 16 (p=0.069). In this clinical trial, there was an unexpected improvement in cognition in the placebo group at week 16 versus baseline.
On other secondary endpoints, including clinical global impression of change (ADCS-CGIC) and the Neuropsychiatric Inventory (NPI) there was no statistical difference between placebo and either 200 or 400 micrograms bid after 4 months treatment. However, there was a trend to improvement on activities of daily living (ADCS-ADL) with 400 micrograms bid (p=0.077). Huperzine A was safe and well tolerated. Overall the incidence of adverse events during the study was similar between both doses of Huperzine A and placebo.
Gary T. Shearman, Ph. D. President and Chief Executive Officer of Neuro-Hitech stated, "Although this clinical trial did not meet the primary endpoint, we are encouraged that the higher dose of Huperzine A studied improved cognitive performance compared to placebo and that the drug was safe and well tolerated in mild to moderate Alzheimer's patients. The main purpose of this Phase 2 clinical trial was to gather data to inform us on the appropriate design of the pivotal Phase 3 registration studies required for marketing approval of Huperzine A."
Paul Aisen, MD, Director of the ADCS, Professor of Neurosciences at the University of California, San Diego and Principal Investigator for this clinical study stated, "This US Phase II trial has clearly demonstrated efficacy of Huperzine A in the treatment of AD. Completion of the planned analyses, including examination of drug levels and cholinesterase inhibition, will be valuable in the design of further studies. I look forward to continued development of the compound with exploration of possible disease-modifying effects." Following completion of the double-blind part of this clinical trial, subjects were invited to receive Huperzine A treatment in an open-label fashion for up to one year. http://www.nutraingredients.com
The phase 2 clinical trial was conducted in the United States in collaboration with the National Institute on Aging and the Alzheimer's Disease Cooperative Study Group (ADCS). The study is a multi-center, randomized, double-blind, placebo-controlled trial in 210 patients with mild to moderate Alzheimer's disease. The trial compared the safety, tolerability and efficacy of either 200 or 400 micrograms of Huperzine A administered orally twice a day for 16 weeks versus placebo. The study measured the efficacy of Huperzine A on cognitive function, activities of daily living and behavior. Of the 210 patients enrolled in this study approximately half received concomitant treatment with Namenda® an FDA approved drug for Alzheimer's disease.
Results showed that there was no statistical difference in the mean change on AD Assessment Scale- Cognitive (ADAS-Cog) scores, the primary endpoint, after 16 weeks treatment with Huperzine A 200 micrograms bid compared to placebo (p=0.81). However, data demonstrated that the higher dose tested, 400 micrograms bid, showed cognitive enhancement on the ADAS-Cog versus placebo. The maximum cognitive improvement was observed at week 11 of treatment (p=0.001). Over 16 weeks Huperzine A (400 micrograms bid) improved cognition compared to placebo (p=0.03) and there was a trend to cognitive improvement over placebo at week 16 (p=0.069). In this clinical trial, there was an unexpected improvement in cognition in the placebo group at week 16 versus baseline.
On other secondary endpoints, including clinical global impression of change (ADCS-CGIC) and the Neuropsychiatric Inventory (NPI) there was no statistical difference between placebo and either 200 or 400 micrograms bid after 4 months treatment. However, there was a trend to improvement on activities of daily living (ADCS-ADL) with 400 micrograms bid (p=0.077). Huperzine A was safe and well tolerated. Overall the incidence of adverse events during the study was similar between both doses of Huperzine A and placebo.
Gary T. Shearman, Ph. D. President and Chief Executive Officer of Neuro-Hitech stated, "Although this clinical trial did not meet the primary endpoint, we are encouraged that the higher dose of Huperzine A studied improved cognitive performance compared to placebo and that the drug was safe and well tolerated in mild to moderate Alzheimer's patients. The main purpose of this Phase 2 clinical trial was to gather data to inform us on the appropriate design of the pivotal Phase 3 registration studies required for marketing approval of Huperzine A."
Paul Aisen, MD, Director of the ADCS, Professor of Neurosciences at the University of California, San Diego and Principal Investigator for this clinical study stated, "This US Phase II trial has clearly demonstrated efficacy of Huperzine A in the treatment of AD. Completion of the planned analyses, including examination of drug levels and cholinesterase inhibition, will be valuable in the design of further studies. I look forward to continued development of the compound with exploration of possible disease-modifying effects." Following completion of the double-blind part of this clinical trial, subjects were invited to receive Huperzine A treatment in an open-label fashion for up to one year. http://www.nutraingredients.com
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