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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)

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Aug 1, 2026 to Dec 1, 2026 Eligibility criteria expanded, about 10 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 10 words
  2. Notable Start date: Mar 1, 2026 to Aug 1, 2026 Primary and study completion dates: May 31, 2027 to Aug 31, 2027 · Secondary endpoints expanded, about 28 wordsv3 Show 2 more changesShow less
    • Primary and study completion dates: May 31, 2027 to Aug 31, 2027
    • Secondary endpoints expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Start date: Oct 1, 2025 to Mar 1, 2026v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07127133
Lead Sponsor HealthPartners Institute
Collaborators: National Institute on Aging (NIA), Innovative Design Labs
Conditions Mild Cognitive Impairment (MCI), Dementia
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov