WASHINGTON — 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 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. 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 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 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 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, such as untreated diabetes, thyroid conditions or toxic interactions among prescription medications.
Duffy said his tool holds promise as a relatively inexpensive and easy way to test people's memory and ability to think.
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 stages of dementia, as the dots move around, changing their direction, speed and intensity.
Other parts of the test challenge memory recall or the ability to recognize letters and shapes.
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.