Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-04 @ 11:11 PM
Study NCT ID:
NCT07127133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-04
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2025-07-11', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'description': 'Mean Absolute Error (MAE) of the gait speed during the Short Physical Performance Battery (SPPB) and Timed Up and GO (TUG)'}, {'measure': 'In-Community Testing Primary Outcome: balanced accuracy of model developed using gait data', 'timeFrame': 'One week', 'description': 'Balanced accuracy of cognitive impairment classification. This is the mean between recall of the positive and negative classes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment (MCI)', 'Dementia']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55 or older\n* 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\n* Ability to understand and provide informed consent, or has a legally authorized representative (LAR) to provide consent on their behalf\n* Ability to don and doff the insole and leg module independently or have assistance for the duration of the study\n\nExclusion Criteria:\n\n* Non-English Speaking\n* Use of ankle-foot orthosis for ambulation that prevents use of the system\n* Self-reported acute thrombophlebitis including deep vein thrombosis\n* Untreated lymphedema or lesion of any kind, swelling, infection, inflamed area of skin or eruptions on or near product use (foot and ankle)\n* Untreated fractures in the foot and ankle\n* Any other significant medical condition that may affect participation or performance in the study, as determined by investigators'}, 'identificationModule': {'nctId': 'NCT07127133', 'briefTitle': "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)", 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': "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)", 'orgStudyIdInfo': {'id': 'A24-016'}, 'secondaryIdInfos': [{'id': 'R44AG063679', 'link': 'https://reporter.nih.gov/quickSearch/R44AG063679', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individuals using the insole and ankle device', 'description': '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', 'interventionNames': ['Device: Insole and ankle device']}], 'interventions': [{'name': 'Insole and ankle device', 'type': 'DEVICE', 'description': 'Device that is worn as a shoe insole and around the ankle which will measure gait parameters to detect cognitive decline', 'armGroupLabels': ['Individuals using the insole and ankle device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'clinicaltrials@healthpartners.com', 'phone': '651-495-6363'}, {'name': 'Amanda Herrmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HealthPartners Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Innovative Design Labs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}