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Life sciences · Interventional Study
ClinicalTrials.gov · September 15, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07127133). This is a study registration, not published results. Lead sponsor: HealthPartners Institute. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Mild Cognitive Impairment (MCI), Dementia. Interventions: DEVICE: Insole and ankle device. Primary outcome measures: In Lab Testing Primary Outcome: Mean absolute error of gait speed from the Short Physical Performance Battery and Timed Up and Go , Day 1; In-Community Testing Primary Outcome: balanced accuracy of model developed using gait data , One week. Brief summary: This study tests an innovative system and service for collecting objective, consistent, and in-community gait parameters suitable for use as AD/ADRD biomarkers. The system is designed to be affordable, scalable, and practical for longitudinal, unsupervised, in-community use by older adults, including those with dementia symptoms. This study will be performed in two parts and involves collecting gait data from participants using the leg module and insole device either (1) for several hours in a lab setting (in-lab testing) or (2) within their home and community for 1 week (in-community testing). Thirty people who are healthy, have mild cognitive impairment, or who have Alzheimer's disease or related dementia will be recruited to participate in the in-lab testing, in which they will perform walking tasks and cognitive testing for several hours within a lab environment. After completion of in-lab testing, 120 individuals who are healthy, have mild cognitive impairment, or who have Alzheimer's disease or related dementia will be recruited to participate in the in-community testing, in which they will wear the insole and ankle device within their community for 1-week for collection of gait data in real world settings.