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)

NCT ID: NCT07127133

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2027-05-31

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

Mild Cognitive Impairment (MCI); Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Individuals using the insole and ankle device

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

Group Type: EXPERIMENTAL

Insole and ankle device

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Innovative Design Labs

INDUSTRY

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Countries

United States

Facility Contacts

Clinical Research Coordinator

Role: primary

clinicaltrials@healthpartners.com

651-495-6363

Other Identifiers

R44AG063679

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A24-016

Identifier Type: -

Identifier Source: org_study_id