FDA Clears Language Independent Computerized Test to Detect Cognitive Impairment

The Food and Drug Administration (FDA) has cleared the CognICA Integrated Cognitive Assessment (ICA) test to be marketed as a medical device to detect cognitive impairment. 

CognICA is a 5-minute, language-independent cognitive assessment delivered on an iPad. The rapid visual categorization test displays images of animals and asks the user to classify the image as either animal or nonanimal.

By using animal images, the test avoids cultural or educational bias and can be used repeatedly with no learning effect. Data from the assessment can be integrated with existing electronic health record systems.

In a study involving 230 participants (95 healthy, 80 with mild cognitive impairment, and 55 with mild Alzheimer disease), the ICA test, “demonstrated convergent validity with MoCA (Montreal Cognitive Assessment) (Pearson r=0.58; P <.0001) and ACE (Addenbrooke’s Cognitive Examination) (r=0.62; P <.0001).” Findings showed that the ICA test was sensitive enough to detect cognitive impairment in the early stages and could potentially be used as a monitoring tool both in the clinic and remotely.

CognICA is expected to be available nationwide in the US in the coming months.

References

1. Cognetivity Neurosciences granted FDA clearance for commercial distribution of ICA throughout US healthcare market. News release. Cognetivity Neurosciences Ltd. October 20, 2021. Accessed October 22, 2021. https://cognetivity.com/cognetivity-neurosciences-granted-fda-clearance-for-commercial-distribution-of-ica-throughout-us-healthcare-market/. 
2. Kalafatis C, Modarres MH, Apostolou P, et al. Validity and cultural generalizability of a 5-minute AI-based, computerized cognitive assessment in mild cognitive impairment and Alzheimer’s dementia. Published online July 22, 2021. Frontiers in Psychiatry. doi.org/10.3389/fpsyt.2021.706695.