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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 week

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an insole and ankle device can track walking patterns that may be signs of Alzheimer's disease or related dementias. It is for adults age 55 or older who are healthy, have mild memory or thinking problems, or have dementia. Participants use the devices for several hours in a lab or for 1 week at home and in their community.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 55 or older.
  • You can complete walking and movement tests without a walking aid.
  • You can understand and agree to join the study, or a legally approved person can agree for you.
  • You can put on and take off the devices yourself, or have help throughout the study.

Who can't join

  • You do not speak English.
  • You use a foot and ankle brace for walking that prevents use of the devices.
  • You report having a recent inflamed vein with a blood clot, including a clot in a deep vein.
  • You have untreated swelling from fluid buildup, a sore, other swelling, infection, or irritated skin on or near your foot or ankle.
  • You have an untreated broken bone in your foot or ankle.
  • The study team decides that another major health condition could affect your ability to take part or complete study tasks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MN