Clinical trials to gain FDA approval for computerized cognitive training: What is the ideal control condition?

Abstract

The explosive growth of mobile technologies combined with the rapid rise of aging populations fearful of their risk for Alzheimer's disease has led to a number of marketed products aimed at enhancing cognitive health. However, an increasing number of product claims that are not substantiated has led regulatory agencies, such as the Federal Trade Commission (FTC), to issue warnings or penalties against some companies. Therefore, it is likely that a number of computerized cognitive training (CCT) companies will conduct clinical trials to prove their efficacy to gain Food and Drug Administration (FDA) clearance as a medical software/device. This raises a number of issues such as optimal trial design for establishing efficacy. The type of control condition is unique issue for CCT, given the variety of non-specific known to produce beneficial effects on cognition that are difficult to isolate from the content of the program. These include participant expectancy, engagement, motivation, novelty, and therapist interaction. We herein discuss the types of non-specific factors, desirable qualities of an active control condition, and the nuances that exist between previously used control conditions within the context of CCT for mild cognitive impairment.