More Choices for In-Office Cognitive Assessment Tools
Written by Editor   
Thursday, August 27, 2015 09:08 PM

Tools newly approved by the US Food and Drug Administration (FDA) to measure and monitor cognition aim to make in-office cognitive assessment faster and simpler. 

One of these is Cognivue (Cerebral Assessment Systems Inc), a computer-based tool designed to better and more easily assess, measure, and monitor brain function to detect early signs of dementia, according to a company press release issued in June at the time of FDA approval.

The noninvasive tool is sufficiently unique that the FDA has created a new class of devices, designated "cognitive assessment aids," the statement notes.

For the assessment, a patient sits in front of a computer screen and is presented with a series of visual stimuli at varying signal strengths with a moving domain-specific target. The patient identifies the target location by moving the cursor using a one-handed steering wheel called a manipulandum. The score is based on the timing and accuracy of responses.

The assessment, which is reimbursable, can be administered in any exam room or primary care office by physician assistants, nurse practitioners, and other midlevel providers, the company said.

Early detection of dementia using Cognivue will allow physicians to begin treatment earlier and monitor its effectiveness and to halt ineffective treatments, according to the release.

The tool is an assessment aid for patients 55 years and older to determine level of cognitive functioning and does not provide a clinical diagnosis. It is not intended as a stand-alone diagnostic device.

Cognivue stemmed from National Institutes of Health–funded basic research in cognitive neurology. According to background information in the release, it's based on an approach referred to as "cognitive psychophysics": engaging patients in continuous stimulus-response paradigms that demand an intervening cognitive process. By enabling the measurement of focal cortical function and the comparison of this to individual and group performance standards, this approach may help clinicians detect and monitor cognitive impairment.

The company provided the FDA with results of two separate studies. The study found that for all cutoff scores, Cognivue provides an acceptable adjunctive tool for recognizing patients with relevant scores.  The second study was a clinical validation study.  According to the FDA website, the Cognivue cognitive screening tool "allows the clinician to integrate the results of the cognitive assessment into their clinical decision making regarding the need for a further diagnostic work-up to determine both the presence and etiology of any suspected cognitive impairment. Additional benefits include the utility of a relatively brief cognitive screening tool that is non-invasive and can be administered by a non-clinician.”  The FDA concluded that the probable benefits of Cognivue outweigh the probable risks.