NCT07127133 · NOT YET RECRUITING
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)
This trial is testing a wearable insole and ankle device that tracks how people walk. The idea is that changes in gait, meaning the way you move when you walk, may serve as early markers of cognitive decline. Researchers want to see if this device can collect reliable walking data both in a lab and at home over one week. This is a Phase NA feasibility study, meaning it is focused on whether the device works, not on treatment.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-24