FDA Approves Tool for Diagnosing Dementia in Dr’s Office

A small company started by a neuroscientist at the University of Rochester has moved closer to providing doctors with what he says is a simple, computer-based tool to help detect early signs of Alzheimer’s disease or other forms of dementia.

Cerebral Assessment Systems, Inc. has received marketing approval by the U.S. Food and Drug Administration for Cognivue, a cognitive-assessment tool that functions somewhat like a video game. A patient can perform the inexpensive and simple test while a time-strapped primary care physician attends to other patients. Yet, the 10-minute, noninvasive examination can detect subtle lapses in the brain’s perceptual ability that may signal the early stages of mental decline caused by dementia.

The federal government’s approval to market the device comes as Alzheimer’s researchers everywhere step up the pursuit for easier and more inexpensive ways to identify dementia in its earliest stages.

“Look, there is a late-life tsunami of late life cognitive decline coming at us. And health care providers are standing on the beach,” said Charles J. Duffy, a neurology professor at the University of Rochester Medical Center who founded the company. “What we are all about is making cognitive care part of primary care.”

More than 5 million Americans have Alzheimer’s disease, the leading cause of dementia. That number is expected to reach 13.5 million by 2050, according to the Alzheimer’s Association. With the United States shifting toward an older society, the hope is that earlier detection can also lead to earlier intervention to slow or arrest the disease, perhaps through medications working their way to the market or changes in lifestyle. In addition to Alzheimer’s, a person’s mental competency can be hindered by other conditions, too, such as untreated diabetes, thyroid conditions or toxic interactions among prescription medications.

“Dementia is the gorilla in the corner of the room in every primary care visit with every older adult,” Duffy said. “And doctors have not been provided with the tools to address that.”

Duffy said his tool holds promise as a relatively inexpensive and easy way to test people’s memory and ability to think. One nurse told him it was easier to use than a microwave oven.

With Cognivue, patients sit before a video screen that shows a series of images, such as a group of dots, that move around and fluctuate in clarity. Using a rotary-shaped mouse–called a manipulandum–the patients try to follow the dots with a wedge-shaped cursor. The task becomes more difficult, especially for people with early symptoms of dementia, as the dots move around, changing their direction, speed, and intensity.

“All perception is interpretive. And so what we’re doing is measuring that process,” Duffy said. Other parts of the test challenge memory recall or the ability to recognize letters and differentiate shapes.

Duffy turned his focus to cognitive assessments that might help in the fight against neurodegenerative diseases after his mother developed dementia. Then in her 80s, she showed the first signs of dementia when she became disoriented in his house, which she had visited many times. Worse, she had trouble remembering her grandson’s name. She died in 2001, he said.

“This is a horrendous curse, and a progressively unrelenting disease,” Duffy said.

Cerebral Assessment System’s device received de novo approval from the FDA, a streamlined process for reviewing medical devices that appear to be new enough to have no equivalent and pose little risk.

The Pittsford, N.Y.-based company’s FDA application included data from a comparative study involving 401 people recruited from 13 communities for older adults. The subjects, ranging in age from 55 to 95, were classified in three groups based on cognitive abilities: normal, mildly cognitive impairment and impaired. Their performance on the Cognivue device was compared to their scores on an existing cognitive assessment test known as the St. Louis University Mental Status Examination (SLUMS).

The device would be available only for use by medical professionals as part of a more comprehensive assessment of cognitive function. It is not intended to be a stand-alone diagnostic tool, and its effectiveness for people with less than 12 years of education is not proven.

Linda M. Rice, a primary care internist with about 1,200 patients in her Rochester practice, said that after a year of using the device in her clinic, she’s been persuaded of its worth . About half of her patients are older than 65, and they often have questions about memory loss and cognitive abilities.

But her options so far for rating their performance involve administering theMini-Mental State Exam (MMSE), also known as the Forstein test, that uses a 30-point questionnaire. The test, which has been around since 1975, offers only a broad indication of cognitive abilities and fails to pick up borderline problems, she said.

“You have to be pretty bad to do poorly on this exam,” she said.

But the alternative involves referring patients for a battery of neuropsychiatric tests that can take hours to complete and cost $1,000 or more. The computer-based tool created by Duffy has promise of being more accurate and just as convenient as the MMSE, she said. It has also helped her to convince some patients that it’s time to stop driving, and start them on medications sooner to slow the progress of Alzheimer’s.

“I think it’s a really potentially valuable tool,” said Leslie Algase, an internist who attends about 2,000 patients in Rochester, at least 30 percent of whom are older than 65. Algase, who said she has no financial ties to the company, agreed to use the Cognivue in her practice about three years ago after meeting Duffy at a conference.

Algase rates the device about as accurate as the MMSE. But Algase said it’s more convenient and less time-consuming to administer. Patients can take the test while the doctor is seeing to other tasks, she said. And the results are objective and simple to interpret.

“It’s a pretty good way to figure out who needs extra testing. It’s also pretty useful for testing the people who are worried about losing their marbles, the worried well who lose their car keys,” she said.

A perfect score can allay their fears, or the worries of people who had a parent or another relative who developed Alzheimer’s, Algase said. “Often times people work themselves into a tizzy that now it’s happening to them.”