The Journal of Prevention of Alzheimer's Disease

Real-time capture of gait and actigraphy using industry-grade wearable devices in older adults with and without subjective cognitive decline: Preliminary compliance, senitivity, and correlations with cognition

A. Atkins, W. Horan, M. Kraus, J. Linthicum, R. Keefe

Verasci – Durham, Nc, USA


real-time, gait analysis, wearable


Background: With improved healthcare, the Down syndrome (DS) population is both growing and aging rapidly with a life expectancy of >55 years of age compared to just 25 year of age in the 1980’s. It is estimated that there are 210 K people with DS in the USA and 40% are over the age of 30 years old (1). However, with longevity comes a very high risk of Alzheimer’s disease (AD). It is estimated that by age 55–60 years at least 70% will develop Alzheimer’s dementia (2, 3). Despite the Alzheimer’s crisis facing the DS population, very few people with DS have participated in clinical trials. Objectives: The challenges in clinical trial recruiting for sporadic AD participants have been widely explored in academic and commercial site settings, including discussions at scientific conference and in scientific publications. And while many of those presentations focus on operational challenges, success in meeting enrollment goals is not simply about advertising and outreach (4). The DS population has unique needs, which are unlikely to be the same as needs of participants with sporadic AD. However, in the case of older adults with AD, familial guardians may have more similar beliefs and needs of spousal caregivers of those with early AD. Method: LuMind IDSC has partnered with Eli Lilly & Company to collect qualitative data from potential participants with DS and their guardians regarding their beliefs about clinical trial participation and experiences with the US medical system. The data will look holistically at lifestyle and be segmented by parental (and potential participant) age, with an attempt to collect data from a variety of residential situations to compare with experiences and beliefs of participants and caregivers in sporadic AD studies. Results: This talk, given by the lead author, will explore common barriers to the recruitment of AD studies, with a comparison of the special needs and potential solutions for adults with DS. DS organizations, such as LuMind IDSC, continuously work to gain the trust of participants and their families in ethical research which is a key component for successful recruitment. Lilly and LuMind will share data that support the development of strategies and tools to engage, support and educate adults with DS and their caregivers about clinical trials, and improve their experience at clinical trial sites. Conclusion: Unique recruitment strategies are needed for successful enrollment of adults with DS in AD trials. Existing Alzheimer’s disease clinical trial sites will need new strategies and tools and need to modify their recruitment techniques from sporadic AD when they study patients with DS. Some of these new solutions may have spillover benefit into recruiting for sporadic AD clinical trials.

Moticon's Summary

This paper presents preliminary results for a larger scale study where it is aimed to evaluate the usage of wearable sensor devices in clinical trials. The participants include healthy older adults (age 55 or greater) as well as older adults with subjective cognitive decline (SCD). The preliminary study includes 38 participants with the aim to increase sample size to 100 participants. Participants were included to the SCD group based on a test score of 4 or higher on the cognitive functional instrument (CFI). Besides another wearable sensor, Moticon sensor insoles were selected for the acquisition of gait data. For testing participants needed to complete four lab-based mobility tests. After the initial testing participants were sent home for a week of continuous data collection. After that the lab-based testing was repeated. Based on their preliminary results, the authors found usage of the selected wearables to be feasible with proper support and maintenance.

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