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)

NCT07127133 | Not Yet Recruiting

• 2 other identifiers: A24-016R44AG063679
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Dementia; Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (2)

• In Lab Testing Primary Outcome: Mean absolute error of gait speed from the Short Physical Performance Battery and Timed Up and Go

  Mean Absolute Error (MAE) of the gait speed during the Short Physical Performance Battery (SPPB) and Timed Up and GO (TUG)

  Day 1

• In-Community Testing Primary Outcome: balanced accuracy of model developed using gait data

  Balanced accuracy of cognitive impairment classification. This is the mean between recall of the positive and negative classes.

  One week

Secondary Outcomes (3)

• In Lab Testing Secondary Outcome: Average score on user feedback survey

  Day 1

• In Community Secondary Outcome: Average score on user feedback survey

  1 week

• In Community Secondary Outcome: Device Failure Rate

  1 week

Study Arms (1)

Individuals using the insole and ankle device

EXPERIMENTAL

Participants will use the wearable leg module and insole device for either several hours in a lab environment or 1 week within their home and the community. Data will be recorded by the device

Device: Insole and ankle device

Interventions

Insole and ankle device DEVICE

Device that is worn as a shoe insole and around the ankle which will measure gait parameters to detect cognitive decline

Individuals using the insole and ankle device

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• National Institute on Aging (NIA): collaborator
• Innovative Design Labs: collaborator

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 17, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)