Clinical trial design of serious gaming in mild cognitive impairment

The “Global Impact of Dementia: 2013–2050” (Alzheimer's Disease International, 2013), released ahead of the December 2013 G8 Dementia Summit in London, estimated that 44.35 million people in the world were living with dementia in 2013. This number was predicted to increase to 75.6 million in 2030, and 135.5 million in 2050. This dramatic increase will have profound implications for social and economic costs (Alzheimer's Disease International, 2010). Since the most common dementia subtype (50–75%) is Alzheimer's disease (AD), its early detection and clinical effectiveness of its prevention and treatment represent a major public health concern and have been identified as a research priority (Alzheimer's Disease International, 2009; Ballard et al., 2011; Foster et al., 2014). Recently, there has been a growing interest in employing Information and Communication Technologies (ICT) to evaluate patient's cognitive and functional impairment for early detection of AD (Wan Shamsuddin et al., 2011; Tarnanas et al., 2014). Beyond being important for assessment, ICT can also play a key role in the patient's treatment, stimulation, and rehabilitation (Robert et al., 2014). This is the idea underlying the current use of Serious Games (SGs), which are a broader reapplication of videogames resources integrating gaming and serious purposes. Lately, a few studies have started to investigate the efficacy of SGs used as an ICT intervention, which target cognitive decline, in people with AD and mild cognitive impairment (MCI). Until now, however, rigorous studies are still lacking. To overcome the current methodological issues 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, Foster et al., 2014), the purpose of the present opinion paper is to highlight the importance of defining harmonized SGs parameters, and to propose the implementation of biomarkers as enrichment strategy and outcome measures in SGs trial design. We will now review the history and state-of-art types and use of SGs, before describing in more detail our proposal.