Neuroscience company Cognivue announced that it will launch a large-scale US 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.
There will be two arms to the study including one for Cognivue’s ten-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. According to the company, Cognivue technology is “simple to implement in any clinical environment and requires minimal staff involvement.” The devices are said to “fold up like a laptop and weigh less than eight pounds for easy portability to various locations inside and outside of the clinic.”
Cognivue President and CEO Tom O’Neill said, “Cognivue is making significant investments in clinical studies to further solidify our leadership position in the cognitive screening and assessment space. 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.”
The FOCUS study will include 2,000 participants in up to 14 cities to ensure a diverse population for robust data capture. Cognivue says it 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.”
James E. Galvin, MD, MPH, Professor of Neurology and Psychiatry and Behavioral Sciences at the University of Miami Miller School of Medicine and a Cognivue Advisory Board Member is serving as the primary investigator.
Galvin said, “The investments that Cognivue is making for studies like the FOCUS trial have critical importance for further verifying and developing the company’s technology and ultimately improving outcomes for patients. I am very pleased to be a part of this study as lead investigator.”
The first patient is expected to begin the study in August, with completion approximately five months later.
About Cognivue, Inc.
Cognivue, Inc is a neuroscience company focusing on cognitive health with “the world’s first FDA-cleared computerized test of cognitive function.” The Cognivue device and technology are based on years of research that uses adaptive psychophysics to focus on information processing by testing key cognitive domains. The technology helps “significantly improve the ability of healthcare providers to implement a personalized assessment of cognitive function in a wide variety of care settings.”
For more information, call (585) 203-1969 or visit cognivue.com.