An Insole and Ankle Device for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer'… (NCT07127133) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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)
United States150 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
In Lab Testing Primary Outcome: Mean absolute error of gait speed from the Short Physical Performance Battery and Timed Up and Go
Timeframe: Day 1
2
In-Community Testing Primary Outcome: balanced accuracy of model developed using gait data