Cognoptix has reported the results of a multicenter clinical trial of its SAPPHIRE II eye test, designed to identify Alzheimer’s disease (AD) patients via a beta-amyloid (A-beta) signature in their eyes, have been published in the latest issue of the peer-reviewed Journal of Alzheimer’s Disease & Other Dementias (AJA).
By detecting a specific fluorescent signature of ligand-marked A-beta 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 the easy-to-use SAPPHIRE eye test has demonstrated the clinical potential to remake the paradigm for the way in which Alzheimer’s disease is currently diagnosed and managed.
Cognoptix president and CEO Paul Hartung said the company is delighted with the results of this feasibility study, which demonstrates the safety and effectiveness of its product, and are honored to have its work recognized in a well-respected, peer-reviewed journal.
"Our vision is to help change the course of Alzheimer’s disease by enabling early diagnosis at point-of-care," Hartung added.