Massachusetts medical device maker Cognoptix launched a clinical trial of its Sapphire II eye exam, assessing its potential for diagnosing early stages of Alzheimer’s disease by detecting certain biomarkers in the eye.
The non-invasive exam looks for traces of beta amyloid peptides, a hallmark of Alzheimer’s disease which grows in parallel in the eye as well as in the brain, according to the company.
"Cognoptix is going to change the course of Alzheimer’s disease by detecting it early," president & CEO Paul Hartung said in a corporate video. "We know our technology works. We’re moving forward aggressively with clinical trials to get this to market."
The exam is a 2-part drug and device combination. The night prior to the eye exam the patient applies a layer of ointment to the eyelid, and the next morning a physician captures a photo of the inner eye.
The in-office procedure is quick and much more cost-effective than performing a brain scan to search for traces of beta amyloid, the company noted.
Building on the success of proof-of-concept studies, the company launched a 40-patient clinical trial of the Sapphire II system.
"There is no early-stage, non-invasive diagnostic test for Alzheimer’s disease in the market," Hartung said in prepared remarks. "This is very unfortunate because patients often incur up to one-half of neuronal loss and a delay of up to 24 months before exhibiting severe enough symptoms to be diagnosed by the current gold standard: a ‘process of elimination’ of other potential diagnoses including stroke, trauma, Parkinson’s disease and dementia, by means of extensive cognitive and physical testing."
"Cognoptix is developing a simple system of early-stage diagnosis to allow treatment before significant neuronal loss and irreversible brain damage happens," Hartung added.