Clinical trial design of Serious Gaming in mild cognitive impairment

Recently, there has been a growing interest in employing Information and Communication Technologies to stimulate and rehabilitate patients' cognitive and functional impairment. This is the idea underlying the current use of Serious Games (SGs), that are a broader reapplication of videogames resources integrating gaming and serious purposes, like education, training, health, etc., and may fall under the umbrella of non-pharmacological treatments. Lately, a few studies have started to investigate the efficacy of SGs used as an ICT cognition-focused intervention in people with Alzheimer's disease (AD) and mild cognitive impairment (MCI). Despite the promising results, rigorous feasibility and efficacy studies are still missing. To overcome these methodological issues, quite common in cognition-focused interventions, and to evaluate the efficacy of SGs in secondary prevention (that currently is being pursued and is considered one of the potentially attainable goals of treatment), we propose to implement in the SG trial design: (i) a biomarker enrichment strategy to recruit MCI due to AD, stratifying enrolled patients into different groups based on positivity/negativity of biomarkers, and (ii) the use of biomarkers as outcome measures in combination with clinical ones. Lastly, a definition of harmonized SGs parameters could be very relevant to consider for designing more robust SG trials.