Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials

Reducing fall risk with combined motor and cognitive training in elderly fallers

Background. Falling is a major clinical problem in elderly people, demanding effective solutions. At present, the only effective intervention is motor training of balance and strength. Executive function-based training (EFt) might be effective at preventing falls according to evidence showing a relationship between executive functions and gait abnormalities. The aim was to assess the effectiveness of a motor and a cognitive treatment developed within the EU co-funded project I-DONT-FALL. Methods. In a sample of 481 elderly people at risk of falls recruited in this multicenter randomised controlled trial, the effectiveness of a motor treatment (pure motor or mixed with EFt) of 24 one-hour sessions delivered through an i-Walker with a non-motor treatment (pure EFt or control condition) was evaluated. Similarly, a 24 one-hour session cognitive treatment (pure EFt or mixed with motor training), delivered through a touch-screen computer was compared with a non-cognitive treatment (pure motor or control condition). Results. Motor treatment, particularly when mixed with EFt, reduced significantly fear of falling (F(1,478) = 6.786, p = 0.009) although to a limited extent (ES -0.25) restricted to the period after intervention. Conclusions. This study suggests the effectiveness of motor treatment empowered by EFt in reducing fear of falling.Peer ReviewedPostprint (published version

An Italian business case for an eHealth platform to provide remote monitoring and coaching services for elderly with mild cognitive impairment and mild dementia

The purpose of this study was to define a business case for an eHealth platform to provide remote monitoring and coaching services for elderly with mild cognitive impairment and mild dementia in the Italian context. 107 patients with mild cognitive impairment and mild dementia were divided into the intervention and control groups. The data was collected using standardized instruments Clinical Dementia Rating Scale (CDR) and EuroQoL-5D-5L, and tailor-made instruments, such as surveysto technology and healthcare providers, and semi-structured interviews to patients and healthcare professionals. The data that was not collected in the study, was obtained from the scientific literature. Benefit/cost ratio was calculated for three years. The study shows that a digital platform to provide remote monitoring and coaching services for elderly with mild cognitive impairment and mild dementia can be cost-effective from the first year, and can improve care without monetary loss for the healthcareprovider. The key benefits show that the deterioration of the illness is postponed, and that the satisfaction of the patients and the healthcare professionals increases. Therefore, such an eHealth platform can be a worthy investment in Italy, and could beconsidered for wider nation-wide adoption

System development guidelines from a review of motion-based technology for people with MCI or dementia

As the population ages and the number of people living with dementia or mild cognitive impairment (MCI) continues to increase, it is critical to identify creative and innovative ways to support and improve their quality of life. Motion-based technology has shown significant potential for people living with dementia or MCI by providing opportunities for cognitive stimulation, physical activity and participation in meaningful leisure activities, while simultaneously functioning as a useful tool for research and development of interventions. However, many of the current systems created using motion-based technology have not been designed specifically for people with dementia or MCI. Additionally, the usability and accessibility of these systems for these populations has not been thoroughly considered. This paper presents a set of system development guidelines derived from a review of the state of the art of motion-based technologies for people with dementia or MCI. These guidelines highlight three overarching domains of consideration for systems targeting people with dementia or MCI: (i) cognitive, (ii) physical, and (iii) social. We present the guidelines in terms of relevant design and use considerations within these domains and the emergent design themes within each domain. Our hope is that these guidelines will aid in designing motion-based software to meet the needs of people with dementia or MCI such that the potential of these technologies can be realized

Effects of spermidine supplementation on cognition and biomarkers in older adults with subjective cognitive decline (SmartAge)—study protocol for a randomized controlled trial

Background: Given the global increase in the aging population and age-related diseases, the promotion of healthy aging is one of the most crucial public health issues. This trial aims to contribute to the establishment of effective approaches to promote cognitive and brain health in older individuals with subjective cognitive decline (SCD). Presence of SCD is known to increase the risk of objective cognitive decline and progression to dementia due to Alzheimer’s disease. Therefore, it is our primary goal to determine whether spermidine supplementation has a positive impact on memory performance in this at-risk group, as compared with placebo. The secondary goal is to examine the effects of spermidine intake on other neuropsychological, behavioral, and physiological parameters. Methods: The SmartAge trial is a monocentric, randomized, double-blind, placebo-controlled phase IIb trial. The study will investigate 12 months of intervention with spermidine-based nutritional supplementation (target intervention) compared with 12months of placebo intake (control intervention). We plan to recruit 100 cognitively normal older individuals with SCD from memory clinics, neurologists and general practitioners in private practice, and the general population. Participants will be allocated to one of the two study arms using blockwise randomization stratified by age and sex with a 1:1 allocation ratio. The primary outcome is the change in memory performance between baseline and post-intervention visits (12 months after baseline). Secondary outcomes include the change in memory performance from baseline to follow-up assessment (18months after baseline), as well as changes in neurocognitive, behavioral, and physiological parameters (including blood and neuroimaging biomarkers), assessed at baseline and post-intervention. Discussion: The SmartAge trial aims to provide evidence of the impact of spermidine supplementation on memory performance in older individuals with SCD. In addition, we will identify possible neurophysiological mechanisms of action underlying the anticipated cognitive benefits. Overall, this trial will contribute to the establishment of nutrition intervention in the prevention of Alzheimer’s disease

Which strength and balance activities are safe and efficacious for individuals with specific challenges (osteoporosis, vertebral fractures, frailty, dementia)?: A Narrative review

Physical activity guidelines advocate the inclusion of strength and balance activities, twice a week, for adults and older adults, but with caveat that in some individuals there will be certain movements and activities that could lead to adverse events. This scoping review summarizes the evidence about how safe and efficacious these activities are in older adults with specific challenges that might make them more prone to injury (e.g. having recently fractured or at risk of fracture (osteoporosis) or those who are frail or who have cognitive impairment). The review identified that for prevention of falls in people with a falls history and/or frailer older adults, structured exercise programmes that incorporate progressive resistance training (PRT) with increasing balance challenges over time are safe and effective if performed regularly, with supervision and support, over at least 6 months. Some minor adverse effects mainly transient musculoskeletal pain) have been reported. For those with a higher risk of falls and fractures (very poor balance, vertebral fractures), supervised structured exercise programmes are most appropriate. People with diagnosed osteoporosis should be as active as possible and only avoid activities with a high risk of falls if they are naive to those activities. For those in transition to frailty who have poor strength and balance, exercises that are known to help maintain strength and balance (such as Tai Chi) are effective in preventing a decline in falls risk. For the very frail older adult, supervised structured exercise that has PRT, balance training and some endurance work, supervised and progressed by a trained person are advocated

Souvenaid in the Management of Mild Cognitive Impairment: An Expert Consensus Opinion

Background Mild cognitive impairment (MCI) among an aging global population is a growing challenge for healthcare providers and payers. In many cases, MCI is an ominous portent for dementia. Early and accurate diagnosis of MCI provides a window of opportunity to improve the outcomes using a personalized care plan including lifestyle modifications to reduce the impact of modifiable risk factors (for example, blood pressure control and increased physical activity), cognitive training, dietary advice, and nutritional support. Souvenaid is a once-daily drink containing a mixture of precursors and cofactors (long-chain omega-3 fatty acids, uridine, choline, B vitamins, vitamin C, vitamin E, and selenium), which was developed to support the formation and function of neuronal membranes and synapses. Healthcare providers, patients, and carers require expert advice about the use of Souvenaid. Methods An international panel of experts was convened to review the evidence and to make recommendations about the diagnosis and management of MCI, identification of candidates for Souvenaid, and use of Souvenaid in real-world practice. This article provides a summary of the expert opinions and makes recommendations for clinical practice and future research. Summary of opinion Early diagnosis of MCI requires the use of suitable neuropsychological tests combined with a careful clinical history. A multimodal approach is recommended; dietary and nutritional interventions should be considered alongside individualized lifestyle modifications. Although single-agent nutritional supplements have failed to produce cognitive benefits for patients with MCI, a broader nutritional approach warrants consideration. Evidence from randomized controlled trials suggests that Souvenaid should be considered as an option for some patients with early Alzheimer’s disease (AD), including those with MCI due to AD (prodromal AD). Conclusion Early and accurate diagnosis of MCI provides a window of opportunity to improve the outcomes using a multimodal management approach including lifestyle risk factor modification and consideration of the multinutrient Souvenaid

The Gray Matter project: modificating lifestyles to prevent dementia

As dementia aetiology is based on different bio-psychosocial factors, prevention strategies for dementia have recently focused on multi-domain interventions of individuals at risk and/or with a normative cognitive level, encouraging the lifestyle change through combined programs of physical activity, cognitive training, nutrition education and social activities (in chapter 1, a narrative review of these studies is presented). Most of the multidomain intervention aimed on the prevention of cognitive disease are carried on with elderly patients with a mild cognitive decline or on at-risk adult categories. 5 Caregivers of patients with dementia are considered as an at-risk category. The majority of them (86%) are represented by family members (prominently women) who are also defined as “informal caregivers”. They fulfil their caringgiving role from 7 to 11 h a day on average, up to 10-15 h when clinical conditions worsen 10. Informal caregivers have to cope with physical, psychological and social stressors that affect their health conditions and quality of life negatively (Eleuteri et al., 2016). The burdens of caregiving include many things that have been shown to increase the risk of cognitive decline, including chronic stress, social isolation, depression, decreased physical activity, and a shift in eating habits toward more fast food and significantly more weight compared with controls (Vitaliano et al., 1996). This could be connected with the important role that sleep plays between stress and metabolic health (Geiker et al., 2018). Being a caregiver has been found to be a factor affecting negatively sleep quality (Brummett et al., 2006). Interventions to promote positive lifestyles are, therefore, important in order to improve the caregivers’ general health and, specifically, to prevent the cognitive decline. In the second chapter, an article recently published specifies the importance of multimodal interventions in ameliorating caregivers’ health, since complex moderation and mediation effects exist between the different areas involved in the AD risk reduction. The third chapter will, finally, describe the results of the Gray Matter Project, a multidomain pilot RCT, firstly carried out done in Cache County, Utah designed to promote positive changes in lifestyle (exercise, nutrition, cognitive stimulation, social engagement, stress management, and sleep quality), specifically for the purpose of reducing AD risk in family caregivers of elderly with dementia