An Insole and Ankle Device for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD)

Launched by HEALTHPARTNERS INSTITUTE · Aug 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new wearable system made up of a special insole and ankle device that helps measure how a person walks. Researchers want to see if this system can help track changes in thinking and memory skills in older adults who are at risk for Alzheimer’s disease or related types of dementia. The device is designed to be easy to use, affordable, and practical for people to wear at home and in their daily lives without needing help from others.

To join the study, participants need to be 55 years or older, able to walk without using a cane or walker, and able to put on and take off the device by themselves or with help. The study includes people who are healthy, have mild memory problems, or have Alzheimer’s or related dementia. Participants will first do some walking and thinking tests in a lab for a few hours while wearing the device. Then, a larger group will wear the device for one week at home and in their community to collect real-life walking data. This research could help doctors better understand and monitor early signs of cognitive decline using simple, everyday tools.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 55 or older
• • Ability to ambulate without the use of an assistive device. For this study, we will assume participants are ambulatory if they can complete the functional outcome measures (i.e., TUG) without the use of an assistive device
• • Ability to understand and provide informed consent, or has a legally authorized representative (LAR) to provide consent on their behalf
• • Ability to don and doff the insole and leg module independently or have assistance for the duration of the study
• Exclusion Criteria:
• • Non-English Speaking
• • Use of ankle-foot orthosis for ambulation that prevents use of the system
• • Self-reported acute thrombophlebitis including deep vein thrombosis
• • Untreated lymphedema or lesion of any kind, swelling, infection, inflamed area of skin or eruptions on or near product use (foot and ankle)
• • Untreated fractures in the foot and ankle
• • Any other significant medical condition that may affect participation or performance in the study, as determined by investigators