A mid-stage compound named NIC5-15 has shown promise as a safe and efficacious therapy for stabilizing the cognitive impairment experienced by Alzheimer's patients, according to researchers from Mount Sinai School of Medicine.
Phase IIA preliminary clinical findings--presented at the Alzheimer's Association 2009 International Conference on Alzheimer's Disease in Vienna on Sunday--demonstrated the drug's ability to prevent the formation of beta-amyloid, a substance that has been shown to build up in the brains of patients suffering from dementia. And the study lays the foundation for a Phase IIb clinical trial scheduled for launch later this year with funding from the NIH.
"NIC5-15 is part of a new class of natural compound we found to have the potential of precluding the generation of β-amyloid and, eventually, attenuating cognitive deterioration in preclinical models of Alzheimer's disease," said Dr. Hillel Grossman, clinical director of the Mount Sinai Memory and Aging Center. Minneapolis, MN-based Humanetics Corporation has exclusive rights to develop and commercialize NIC5-15 to treat Alzheimer's disease.
Investigators involved in the study gathered preliminary evidence of treatment efficacy, including activities of daily living, behavioral disturbances, pharmacokinetic parameters and a number of Alzheimer's disease biomarkers including Abeta peptide levels. Patients were given escalating oral doses of NIC5-15 over a 45-day period.
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