Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-31 @ 12:23 PM
Study NCT ID:
NCT06994767
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech-derived Digital Biomarkers Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054928', 'term': 'Validation Studies as Topic'}], 'ancestors': [{'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis', 'timeFrame': 'Upon enrollment', 'description': "The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the sensitivity, the application diagnosis will be compared against the clinical diagnosis of the physician."}, {'measure': 'The primary objective of the study is to assess the specificity of vocal biomarkers in patients with MCI and AD diagnosis', 'timeFrame': 'Upon enrollment', 'description': "The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the specificity, the application diagnosis will be compared against the clinical diagnosis of the physician."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vocal biomarkers', 'Mild Cognitive Impairment', "Alzheimer's Disease", 'Deep machine learning', 'Artificial Intelligence application'], 'conditions': ['Mild Cognitive Impairment (MCI)', 'Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '29914025', 'type': 'BACKGROUND', 'citation': "Martinez-Sanchez F, Meilan JJG, Carro J, Ivanova O. A Prototype for the Voice Analysis Diagnosis of Alzheimer's Disease. J Alzheimers Dis. 2018;64(2):473-481. doi: 10.3233/JAD-180037."}, {'pmid': '29669461', 'type': 'BACKGROUND', 'citation': "Mueller KD, Hermann B, Mecollari J, Turkstra LS. Connected speech and language in mild cognitive impairment and Alzheimer's disease: A review of picture description tasks. J Clin Exp Neuropsychol. 2018 Nov;40(9):917-939. doi: 10.1080/13803395.2018.1446513. Epub 2018 Apr 19."}, {'pmid': '37497623', 'type': 'BACKGROUND', 'citation': 'Garcia AM, de Leon J, Tee BL, Blasi DE, Gorno-Tempini ML. Speech and language markers of neurodegeneration: a call for global equity. Brain. 2023 Dec 1;146(12):4870-4879. doi: 10.1093/brain/awad253.'}, {'pmid': '33377800', 'type': 'BACKGROUND', 'citation': 'Sanborn V, Ostrand R, Ciesla J, Gunstad J. Automated assessment of speech production and prediction of MCI in older adults. Appl Neuropsychol Adult. 2022 Sep-Oct;29(5):1250-1257. doi: 10.1080/23279095.2020.1864733. Epub 2020 Dec 30.'}, {'type': 'BACKGROUND', 'citation': "Vinod Subramanian, Namhee Kwon, Raymond Brueckner, Nate Blaylock, Henry O'Connell,"}]}, 'descriptionModule': {'briefSummary': "The goal is to assess the accuracy of an application that analyzes voice characteristics to diagnose patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD). The main question is whether the application's diagnosis is the same as the clinician's for MCI and AD patients.", 'detailedDescription': "The study aims to assess the sensitivity and specificity of an application that uses vocal biomarkers to diagnose patients with mild cognitive impairment (MCI) and Alzheimer's disease. The application will use clinically validated survey instruments and voice recordings to determine the disease status of patients with MCI and Alzheimer's disease. The diagnosis developed by the application is the primary outcome variable. To determine the sensitivity and specificity, the application diagnosis will be compared against the physician's clinical diagnosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females between the ages of 50 and above\n* Willing and capable of participating in all aspects of the study\n* Willing and capable of giving informed consent\n* Diagnosis of MCI or Alzheimer's by the physician\n* For the control group: Without diagnosis of MCI or Alzheimer's or other types of dementia\n* Subjects are free of any medical condition(s) that, according to exclusion criteria, might audibly affect voice characteristics\n* Subject must be able to speak and read with fluency in the English language.\n\nExclusion Criteria:\n\n* All participants below 50 years\n* Failure to provide informed consent\n* Individuals with the following medical conditions will be excluded:\n\n i) Parkinson's disease ii) Huntington's disease iii) Cancer and active cancer treatments\n* Persons with speech characteristics (heavy accents, slurring, stuttering, etc.) that would interfere with voice recording or voice analysis"}, 'identificationModule': {'nctId': 'NCT06994767', 'briefTitle': 'Speech-derived Digital Biomarkers Study', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': "Speech-derived Digital Biomarkers for Assessing Mild Cognitive Impairment and Alzheimer's Disease Diagnosis Accuracy", 'orgStudyIdInfo': {'id': 'Pro2024-0418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild Cognitive Impairment (MCI)', 'description': 'Patients with a mild congitive impairment', 'interventionNames': ['Other: The Canary Application']}, {'type': 'EXPERIMENTAL', 'label': "Alzheimer's Disease", 'description': "Patients with an Alzheimer's Disease diagnosis", 'interventionNames': ['Other: The Canary Application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteers', 'description': "Patients without a diagnosis of MCI or Alzheimer's, or other types of dementia", 'interventionNames': ['Other: The Canary Application']}], 'interventions': [{'name': 'The Canary Application', 'type': 'OTHER', 'otherNames': ['Validation'], 'description': "The CANARY application will use clinically validated survey instruments and voice recordings to measure user MCI status /Alzheimer's data. These tests are designed to evaluate a user's voice characteristics and potentially identify disease-specific patterns.", 'armGroupLabels': ["Alzheimer's Disease", 'Healthy Volunteers', 'Mild Cognitive Impairment (MCI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'centralContacts': [{'name': 'Susan Dara, MPH', 'role': 'CONTACT', 'email': 'susan.dara@hmhn.org', 'phone': '5519965180'}], 'overallOfficials': [{'name': 'Sakshi Jain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canary Speech Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}