Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05340218
Status:
UNKNOWN
Last Update Posted:
2022-04-22
First Post:
2022-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Automated Longitudinal Analysis of Speech and Language in Cognitive Impairment
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Accexible's model performance.", 'timeFrame': 'Every 6 to 9 months', 'description': "Percentage of patients classified correctly compared to the total number of sick patients, visualized at the ROC curve that allows to see the accuracy against the recall of the classifier. To contrast the accuracy of AcceXible's platform as a screening tool in the detection of people with cognitive impairment and mild dementia, a detection model has been developed from the analysis of the participants, acoustic, linguistic and semantic variables have been considered as well as audio characteristics."}], 'primaryOutcomes': [{'measure': 'Pre-post variability of normal, MCI and dementia at both points of the study.', 'timeFrame': 'Change from the baseline cognitive function at 9 months.', 'description': "Through standard deviation of normal subjects, MCI and dementia, variations in language are measured by considering MMSE scores and the most significant variables of accexible's tests (image description test, phonetic verbal fluency test and semantic verbal fluency test)."}], 'secondaryOutcomes': [{'measure': 'Correlation between cognitive tests and language variables obtained by the platform.', 'timeFrame': 'Every 6 to 9 months', 'description': 'Correlation between: Standard measures of cognition (e.g., MMSE score) + behavioral and psychiatric symptoms of mild cognitive impairment and language.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Dementia']}, 'descriptionModule': {'briefSummary': "Validate speech analysis AI models:\n\n* To contrast the accuracy of acceXible's platform as a screening tool in the detection of people with cognitive impairment and mild dementia.\n* To evaluate the correlation between automatically analyzed linguistic variables and a combination of standard measures of cognition.\n* To assess short-term variability in language ability among older adults, and to assess which aspects of language vary during the study period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients 55+ years of age with suspected MCI or diagnosis of dementia and obtains a score greater than 20 on the MMSE.\n* Patients must have agreed to participate in the study and have voluntarily signed the informed consent.\n* (Healthy) Participants without a diagnosis neurological, or psychiatric disorders. Or taking medication that can affect cognitive abilities.\n\nExclusion Criteria\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.'}, 'identificationModule': {'nctId': 'NCT05340218', 'briefTitle': 'Short-term Automated Longitudinal Analysis of Speech and Language in Cognitive Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accexible'}, 'officialTitle': '"Análisis Longitudinal Del Habla y Seguimiento a Corto Plazo de Las Facultades Cognitivas de Personas Mediante Una Serie de Pruebas: Lista de Palabras CERAD, Repite Los dígitos en Orden Inverso, TMTA-B, Prueba Del Reloj, Fluidez fonémica, comprensión Verbal Relaciones semánticas, y semánticas Alternas".', 'orgStudyIdInfo': {'id': '18/475-E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Speech analysis', 'type': 'OTHER', 'description': 'Speech analysis to detect and monitor mild cognitive impairment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Centro de Prevención de Deterioro Cognitivo', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Accexible', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}