FDA Clears 5-Minute Test for Early Dementia

Megan Brooks

October 20, 2021

The US Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia.

Developed by Cognetivity Neurosciences Ltd, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper-based cognitive tests, the company said in a news release.

"These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias and absence of learning effect upon repeat testing," the company notes.

Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.

According to the latest Alzheimer’s Disease Facts and Figures, published by the Alzheimer’s Association, more than 6 million Americans are now living with Alzheimer's disease. That number is projected to increase to 12.7 million by 2050.

"We're excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the US and make a positive impact on the health and wellbeing of millions of Americans,” Sina Habibi, PhD, co-founder and CEO of Cognetivity, said in the news release.

The test has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the UK's National Health Service.

"The test can be downloaded through the Apple App Store and installed directly onto users' iPads. As the test is intended only for clinicians, an account is then applied for and the test can then be used immediately," Thomas Sawyer, PhD, chief financial officer of Cognetivity Neurosciences, told Medscape Medical News.

"The test then only needs an internet connection to transfer data, but tests can be conducted offline and data synchronized when back online again," Sawyer said.

He said the company is in the process of developing a final cost model for the US market. The price will depend on usage levels and will include unlimited use license options. Stand-alone, per-test costs are likely to be in the $20 to $30 range.

More information is available online.

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