Brad Oatney, OD discusses Cognivue assessment results with a Delaware Vision Care patient at his Delaware, Ohio practice.
ROCHESTER, N.Y.—Neuroscience company Cognivue will launch a large-scale U.S. study next month to further differentiate the effectiveness of its cognitive assessment systems. The Further, Objective, Clinical, Understanding Study (FOCUS) is intended to confirm Cognivue total scoring, age-specific normative ranges, test-retest reliability, training effect, sensitivity and specificity as compared to other frequently used paper and digital cognitive screening assessments, the company said in an announcement. There will be two arms to the study including one for Cognivue’s 10-minute self-administered computerized assessment that is based on the company’s patented FDA-cleared technology as well as a second arm that will include Cognivue’s five-minute, self-administered computerized screening of cognitive function.

“Cognivue is making significant investments in clinical studies to further solidify our leadership position in the cognitive screening and assessment space,” said Cognivue president and CEO Tom O’Neill. “We expect this research will further differentiate our patented technology. We anticipate that the findings will expand the existing usage and application of Cognivue assessments in a larger patient population.”

Several studies have shown a correlation between vision and cognitive function, particularly among the elderly. Some optometrists are currently performing Cognivue assessments for patients who are having a comprehensive vision test.

The FOCUS study will include 2,000 participants in up to 14 cities to ensure a diverse population for robust data capture, according to Cognivue. The company will confirm a neutral test application and eliminate common cognitive assessment biases by stratifying the study population by age, sex, education level and hearing thresholds, as hearing is the number one modifiable risk factor for dementia.

The first patient is expected to begin the study in August, with completion expected approximately five months later, Cognivue said.