FDA clears app to screen for cognitive impairment
The FDA recently granted UK-based Cambridge Cognition Holdings 501(k) clearance to market CANTAB Mobile as a device that can detect early stages of clinically relevant mental impairment in older adults.
For older adults, early detection of dementia and Alzheimer’s is crucial for receiving timely treatment and planning the future. The Cambridge Neuropsychological Test Automated Battery (CANTAB) was developed initially more than 30 years ago as a group of tests for use in neurologic and psychiatric research. The Paired Associates Learning (PAL) test is one of the tests to detect features of cognitive impairment that could be signs of early Alzheimer’s disease.
CANTAB Mobile translates the relatively complex, specialist-administered PAL test into a self-guided, iPad-based exam that can be administered at a larger scale, such as in a primary care office or as part of large clinical studies.
Assessment via the medical app is a simple, 10-minute, point-of-care exam anyone can use anywhere. CANTAB Mobile’s platform includes three tests focused on episodic memory, mood, and the ability to perform regular, daily activities. The test also takes age, gender, and education into consideration, and results, in the form of a 1-page physician’s report, can reassure the user or refer patients to next steps.
We’ve seen some other examples of neurologic and psychiatric assessment tools being translated into mobile platforms. One example is the HAND in HAND ResearchKit app from the University of Nebraska, which focused on the cognitive impacts of chronic HIV. In that study, a platform called Brain Baseline was used to offer plug-and-play neurologic assessments.
According to a description of CANTAB Mobile in Translational Neuropsychopharmacology (Robbins et al, Springer, 2016) by researchers from Cambridge Cognition Holdings, about 25% of ~10,000 patients screened in the UK were identified as having clinically significant memory problems. Hopefully, we’ll see more data on the real-world accuracy of large-scale screening using CANTAB Mobile, and the downstream effects of that.