May 23, 2013
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New eye test may provide accurate, low cost mode of diagnosing Alzheimer's

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Cognoptix announced that its Sapphire II eye test identified Alzheimer’s patients via a beta amyloid signature in their eyes in a 10-subject proof-of-concept clinical trial, according to a company press release.

The Sapphire II is an in-office, drug/device diagnostic system designed as an aid in the early detection of Alzheimer’s disease pathology. A ligand or contrast agent and software-controlled optical instrument allows for noninvasive detection and assessment of Alzheimer’s by measuring its hallmark, beta amyloid, in the supranuclear region of the lens of the eye, the release said.

By detecting a specific fluorescent signature of ligand-marked beta amyloid in the supranucleus region of the human lens, Sapphire II achieved a 200% differentiation factor between a group of five healthy volunteers and a group of five patients diagnosed with probable Alzheimer’s disease, according to the release.

The ligand is easily administered to the eye as an ophthalmic ointment, and a proprietary fluorescent ligand scanning instrument provides an objective and quantitative measurement of beta amyloid in the patient’s lens. Significantly faster and an order of magnitude less expensive than brain imaging, the test and diagnosis can be quickly completed in any physician’s office, including general practitioners, the release said.

“There is a significant effort underway in the scientific and medical communities that is investigating the function of beta amyloid neuritic plaques in the brains of adult patients with cognitive impairment and possible Alzheimer’s disease,” said Carl Sadowsky, MD, FAAN, medical director at Premiere Research Institute in West Palm Beach Fla., and a principal investigator in the Sapphire clinical study. “While it is true that positron emission tomography imaging has been approved to enable detection of beta amyloid neuritic plaques in living Alzheimer’s patients, there is, nevertheless, a dire need for a low cost, noninvasive technology capable of upgrading the differential diagnosis of dementia, which would be extremely practical for widespread use at the point-of-care.”

The clinical data are published in the May 2013 edition of Frontiers in Neurology, according to the release.
Sapphire II is not yet available on the market.