Cognivue aims to catch cognitive decline early with a computer-based test that can be administered by primary care doctors.

Marie Thibault

Some memory loss and slower thinking is an inevitable part of aging—right? When does forgetting a face or misplacing the car keys every once in a while become a reason for concern?

Patients with worries about their cognitive function can visit a neurologist at a major medical center to undergo cognitive assessment. However, there are many patients who live in rural areas or don’t have the ability to travel to a specialist. Are they relegated to trying to self-test their cognition with the daily crossword?

Not anymore. In June, FDA granted de novo approval to the Cognivue cognition assessment aid from Cerebral Assessment Systems, Inc. The agency established a new device class for the pioneering test, called “Cognitive Assessment Aids.”

“In my view, cognitive status is a vital sign,” says inventor Charles Duffy, MD, PhD, founder and CEO of Cerebral Assessment Systems. Duffy is a researcher and professor in neurology, ophthalmology, neurobiology, and brain and cognitive sciences at the University of Rochester (New York) Medical Center.

The Cognivue test is run on a normal computer with a modified operating system and special software, so it can be conducted in primary care offices and exam rooms. The assessment only takes about 10 minutes. Patients look at a computer screen and react to stimuli with a response wheel. Cognivue adapts to the patient’s performance, meaning the assessment becomes more or less challenging depending on how the patient is doing.

After taking the test, physicians are given the patient’s composite score as an indication of cognitive status—from normal to impaired, or in between. The scores conjure memories of grade school—a passing score of 75 or higher for a patient who is unimpaired, or a failing score of 50 or lower to signal impairment. Duffy says that he has been told some patients display their score on their refrigerators to show their children, “Look, I’m doing okay!”

Duffy, who has researched brain function for 30 years, realized that it is important to “[make] cognitive care an integral part of primary care.” As a neurologist, he knows that patients have to go to metropolitan areas and major centers in order to find him and his peers for an expert evaluation.

“What we could do is instead use technology to create an artificial intelligence cognitive neurology tool that we could put into the hands of licensed practitioners and empower them to manage late-life cognitive decline as part of their overall healthcare focus,” Duffy says.

Linda Rice, MD, of Northridge Medical Group in Rochester, NY, is a primary care physician whose practice was a test office for Cognivue during the FDA review process. She has used the test on approximately 100 patients.

In an e-mail to MD+DI, Rice explains that “most patients over 50 have memory concerns . . . Before Cognivue we only had tools such as the Mini-Mental state exam, which will pick up a serious cognitive problem, but not one early on.” What’s more, she notes, formal cognitive assessment is expensive and often not covered by insurance.

“With the Cognivue, you can do a 10-minute test in the office that has very good correlation to formal testing at a fraction of the cost and time, and you get instant results. Those without real cognitive issues do well and can then be reassured that their memory problems are just what I like to call ‘brain clutter’ . . . Before Cognivue, we just had to say ‘time will tell.’”

The test should be affordable to patients, too. Duffy says the Cognivue test is reimbursed under CPT code 96120 to indicate neuropsychological testing administered with a computer.

So when will Cognivue become standard of care? Duffy says he is introducing the test to physicians and medical groups now, and is also discussing potential strategic partnerships for marketing and selling the test.

While it may be early days yet for Cognivue, eventually all patients may be able to get their cognitive composite scores at their yearly checkups. And perhaps there will be more positive stories associated with cognitive function, like this one from Rice about a patient who had previously been told she had dementia: “After a few visits in which she seemed to be thinking pretty normally, I had her do the Cognivue test, and she scored in the normal range! I was able to tell her that she didn’t have dementia at all!”

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

 [Image courtesy of SALVATORE VUONO/FREEDIGITALPHOTOS.NET]