NCT07127133

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)

A Gait and Path Tortuosity System for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mild Cognitive Impairment (MCI)
• Dementia

Interventions

Type	Name	Description
DEVICE	Insole and ankle device	Device that is worn as a shoe insole and around the ankle which will measure gait parameters to detect cognitive decline

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2025-08-17
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States