(BUSINESS WIRE)–Nov 15, 2013–Cognoptix disclosed today at the ‘Clinical Trials on Alzheimer’s Disease’ (CTAD) scientific meeting the strong results of a multi-site clinical trial of its SAPPHIRE II eye test, which is designed to identify Alzheimer’s Disease (AD) patients via a beta-amyloid (Ab) signature in their eyes.
By detecting a specific fluorescent signature of ligand-marked Ab in the supranucleus region of the human lens, SAPPHIRE II achieved a sensitivity of 85% and a specificity of 95% in differentiating 20 patients who were clinically diagnosed with probable AD from a group of 20 age-matched healthy volunteers. In addition, the SAPPHIRE II test showed excellent correlation to PET (positron emission tomography) amyloid brain imaging.
“This simple SAPPHIRE eye test has the potential to change the way that Alzheimer’s Disease is detected and managed,” said Carl Sadowsky, MD, FAAN, Medical Director, Premiere Research Institute, West Palm Beach, Fla., and a principal investigator in the clinical trial of the SAPPHIRE eye test.
“These clinical results give us a great deal of hope that we will eventually be able to intervene early in the course of Alzheimer’s Disease, well ahead of the manifestation of symptoms,” added Maria C. Carrillo, Ph.D., Vice President, Medical and Scientific Relations, Alzheimer’s Association.
“This clinical milestone represents a gigantic step forward in developing an early-stage, non-invasive diagnostic test for AD,” said Paul Hartung, President and CEO of Cognoptix. “The Cognoptix eye test is designed to be a simple but reliable system of early-stage diagnosis to allow treatment before significant neuronal loss and irreversible brain damage occur.”
The clinical investigators and four clinical trial sites included: Costa Mesa, Calif. (ATP Clinical Research Inc., Gus Alva, M.D.); Miami (Miami Jewish Health Systems, Marc E. Agronin, M.D.); Phoenix (Banner Alzheimer’s Institute, Pierre N. Tariot, M.D.); and West Palm Beach, Fla. (Premiere Research Institute, Carl H. Sadowsky, M.D.).
According to the Alzheimer’s Association, AD is the sixth-leading cause of death in the United States: approximately 5.2 million persons are estimated to have AD and dementia, costing the U.S. more than $200 billion annually in medical and personal care expenses. Between 2000 and 2010, deaths from AD increased 68%, while deaths from stroke, heart disease and breast cancer decreased by 42%, 23% and 2%, respectively, according to Data Decision Group.