Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT05534958
Status:
UNKNOWN
Last Update Posted:
2022-09-10
First Post:
2022-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
UK Validation of the Automated "AcceXible" Speech Analysis Software
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Diagnostic performance of Accexible's digital screening battery", 'timeFrame': 'An average of 1 year', 'description': 'Measure the odds that a patient has MCI or dementia measured by vocal biomarkers'}], 'secondaryOutcomes': [{'measure': "Correlation of Accexible's test battery with the ACE III", 'timeFrame': 'An average of 1 year', 'description': "Comparison of Accexible's test battery with ACE III diagnostic predictive value at various cut-off points (e.g. 82 and 88 for ACE III)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment and Dementia']}, 'descriptionModule': {'briefSummary': "Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.\n\nA recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.\n\nThe present study has the objective of validating a digital method for detection and follow-up of patients with mild cognitive impairment (MCI) or dementia in a memory clinic setting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sample:\n\nCases: 125 adult patients \\>55 years with suspected MCI or diagnosis of dementia referred to memory clinic.\n\nControls: 125 healthy adult patients \\>55 years without a diagnosis of MCI and without subjective cognitive complaints.', 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n* Adult patients 55+ years of age with suspected MCI or diagnosis of dementia referred into secondary care memory clinic by their General Practitioner.\n* Have English as first language (able to speak and understand verbal messages).\n* Patients must have agreed to participate in the study and have voluntarily signed the informed consent.\n\nInclusion Criteria for healthy volunteers:\n\n* Healthy older adults (55+ years of age), without a diagnosis neurological, or psychiatric disorders or any clinical evidence of cognitive decline.\n* Have English as first language (able to speak and understand verbal messages).\n* Controls must have agreed to participate in the study and have voluntarily signed the informed consent.\n\nExclusion Criteria for patients:\n\n* To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.\n* To have significant vision problems that would affect the ability to perceive visual stimuli.\n* To have significant hearing problems that would affect the ability to understand verbal cues.\n* To be unable to give informed consent to participate in the study.\n\nExclusion Criteria for healthy volunteers:\n\n* Objective evidence of significant cognitive decline in any one domain.\n* Score of \\<88 on ACE-III cognitive testing.'}, 'identificationModule': {'nctId': 'NCT05534958', 'briefTitle': 'UK Validation of the Automated "AcceXible" Speech Analysis Software', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accexible'}, 'officialTitle': 'Assessing the Diagnostic Accuracy of a Three One-minute Tests of Verbal Fluency, Using Artificial Intelligence, in Detecting Mild Cognitive Impairment and Early Dementia.', 'orgStudyIdInfo': {'id': 'AcceXible-Healthy,MCI,Dementia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'interventionNames': ['Device: Accexible']}, {'label': 'Mild Cognitive Impairment', 'interventionNames': ['Device: Accexible']}, {'label': 'Early Dementia', 'interventionNames': ['Device: Accexible']}], 'interventions': [{'name': 'Accexible', 'type': 'DEVICE', 'description': 'Speech Analysis', 'armGroupLabels': ['Early Dementia', 'Healthy', 'Mild Cognitive Impairment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cornwell', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dr Simon Vann', 'role': 'CONTACT'}], 'facility': 'Cornwall Partnership NHS Foundation Trust', 'geoPoint': {'lat': 51.94141, 'lon': -1.60746}}], 'centralContacts': [{'name': 'Carla Zaldua', 'role': 'CONTACT', 'email': 'carla@accexible.com', 'phone': '+34 649 33 22 95'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Accexible', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cornwall Partnership NHS Foundation Trust', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}