Cognoptix is developing technologies to enable non-invasive quantitative measurements of amyloid aggregates in the eye, to examine and measure deposits in specific areas of the lens as a means of early detection of Alzheimer’s disease.
Cognoptix’s development of the SAPPHIRE platform envisions a compact, easy to use, clinical device for in situ patient examination in a doctor’s office setting.
The combined platform is currently available in the United States for investigational use only, and is intended for clinical evaluation and measurement of aggregation in anatomically defined regions of the anterior segment of the eye.
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, has been published in 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.
“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,” 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.
Fluorescent Ligand Scanning (FLS)
Fluorescent Ligand Scanning (FLS) is a technique in which a compound composed of beta amyloid-specific small molecules is dropped into a patient’s eye, which is scanned by the SAPPHIRE instrument.
The small molecules are absorbed into the lens and bind to the amyloid aggregates. The FLS system excites the fluorescent ligands that bind to amyloid and quantitatively measures emissions in specific anatomical locations to biochemically confirm the presence of amyloid.The binding compounds emit light in a specific, detectable range of wavelengths. If binding increases over time, a positive diagnosis can be made, enabling clinicians to track the progress of the disease in patients by measuring levels of fluorescence – as well as potentially enabling doctors and pharmaceutical researchers to monitor the efficacy of Alzheimer’s drugs in clinical trial settings.