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NIC5-15
The Development of NIC5-15 in the Treatment of Alzheimer's Disease
| Status: | Study Completed |
| Eligible Population(s): | Alzheimer's Disease |
| GCO Number: | 05-0173 IRB approved through 06/30/2009 |
| Principal Investigator: | Hillel Grossman, MD |
| Study Coordinator: | George Marzloff |
Preliminary findings in Phase IIA trial point to natural compound NIC5-15's potential in Alzheimer's disease
View the ICAD 2009 poster [pdf]19 July 2009
Researchers at Mount Sinai School of Medicine have found that a compound called NIC5-15, might be a safe and effective treatment to stabilize cognitive performance in patients with mild to moderate Alzheimer's disease.
The two investigators, Giulio Maria Pasinetti, M.D., Ph.D. , and Hillel Grossman, M.D., presented Phase IIA preliminary clinical findings at the Alzheimer's Association 2009 International Conference on Alzheimer's Disease (ICAD) in Vienna on Sunday, July 12.
NIC5-15's potential to preserve cognitive performance will be further evaluated in a Phase IIB clinical trial. Early evidence suggests that NIC5-15 is a safe and tolerable natural compound that may reduce the progression of Alzheimer's disease-related dementia by preventing the formation of beta-amyloid plaque, a waxy substance that accumulates between brain cells and impacts cognitive function.
"With Alzheimer's disease affecting 5.2 million Americans, another 5 million with early-state disease, and nearly a half million new cases reported annually, treatments like NIC5-15 would make a significant difference in the lives of many Alzheimer's patients," said Dr. Pasinetti, Professor of Psychiatry, Professor of Neuroscience and Professor of Geriatrics and Adult Development, in the Department of Psychiatry at Mount Sinai School of Medicine. "We are hopeful that the follow up clinical study will support this preliminary evidence."
"There are no FDA-approved Alzheimer's disease modifying drugs available today," said Dr. Hillel Grossman, Assistant Professor of Psychiatry, Co-Director of the Clinical Research Core of the Alzheimer's Disease Research Center, and Clinical Director of the Mount Sinai Memory and Aging Center. "Current drugs approved for use help maintain cognitive function, but only for a limited time. NIC5-15 is part of a new class of natural compound we found to have the potential of precluding the generation of ß-amyloid and, eventually, attenuating cognitive deterioration in preclinical models of Alzheimer's disease."
The study was conducted at the Mount Sinai Alzheimer's Disease Research Center (ADRC), a nationally renowned center of excellence since 1984. ADCR is a comprehensive research facility and clinical program dedicated to the study and treatment of both normal aging and Alzheimer's disease. The Center is supported by the National Institute on Aging, a branch of the National Institutes of Health. Humanetics Corporation, manufacturers of NIC5-15, sponsored the study. Phase IIB clinical trials on NIC5-15 are expected to begin later this year.
Disclosure: Dr. Pasinetti has a patent pending for the use of NIC5-15 in the treatment of Alzheimer's disease. The patent application was filed on his behalf by the Mount Sinai School of Medicine. Dr. Pasinetti and the School of Medicine could benefit financially from the results of this trial.