Cognoptix disclosed 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.
Premiere Research Institute medical director West Palm Beach, Florida and a principal investigator in the clinical trial of the SAPPHIRE eye test Dr Carl Sadowsky said, "This simple SAPPHIRE eye test has the potential to change the way that Alzheimer's disease is detected and managed."
Alzheimer's Association vice president, medical and scientific relations Dr Maria C Carrillo said, "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."
Cognoptix president and CEO Paul Hartung said this clinical milestone represents a gigantic step forward in developing an early-stage, non-invasive diagnostic test for AD.
"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," Hartung added.
The clinical investigators and four clinical trial sites included: Costa Mesa, California (ATP Clinical Research Inc., Dr Gus Alva); Miami (Miami Jewish Health Systems, Dr Marc E. Agronin); Phoenix (Banner Alzheimer's Institute, Dr Pierre N. Tariot); and West Palm Beach, Florida (Premiere Research Institute, Dr Carl H. Sadowsky).
