FDA approves Cognivue for diagnosing dementia

Cerebral Assessment Systems has received marketing approval from the FDA for Cognivue, a tool for the early detection of Alzheimer’s

Cognivue is a cognitive-assessment tool, which can help detect early signs of Alzheimer’s disease or other forms of dementia and functions like a video game.

The ten-minute, non-­invasive examination can detect subtle lapses in the brain’s perceptual ability that may signal the early stages of mental decline caused by dementia.

More than 850,000 people in the Uk have Alzheimer’s disease, the leading cause of dementia. That number is expected to reach 1 million by 2025, according to the Alzheimer’s Society

CharlesDuffy, a neurology professor at the University of Rochester Medical Center who founded the company, 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.

Duffy said: “All perception is interpretive, and so what we’re doing is measuring that process.”

Other parts of the test challenge memory recall or the ability to recognise letters and shapes.

The device would be available only for use by medical professionals as part of a more comprehensive assessment of cognitive function.


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