Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 3:40 PM
Study NCT ID:
NCT06789094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-23
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating the Ain Shams Cognitive Assessment Tool
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000073222', 'term': 'Patient Health Questionnaire'}], 'ancestors': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASCA cut off points', 'timeFrame': '4 months', 'description': 'obtain cut-off scores for diagnosing mild cognitive impairment (MCI) and dementia using the Ain Shams Cognitive Assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild cognitive impairment', 'Dementia', 'cognitive assessment', 'Arabic cognitive assessment tools'], 'conditions': ['Mild Cognitive Impairment (MCI)', 'Dementia']}, 'descriptionModule': {'briefSummary': "The diagnosis of cognitive impairment, including dementia and mild cognitive impairment (MCI), is crucial for timely intervention and management. Various screening tools are available for assessing cognitive function, among which the Mini-Mental State Examination (MMSE), the Addenbrooke's Cognitive Examination (ACE), and the Montreal Cognitive Assessment (MoCA) are widely used. However, the recently developed Ain Shams University Cognitive Assessment (ASCA) has shown promise in detecting early cognitive decline. This study aims to assess the performance of ASCA in diagnosing cognitive impairment against DSM5 criteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community dwelling elderly participants (caregivers of inpatients, attendants of primary care , elderly clubs and other community gatherings).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: older adult participants 60 years old and above who are native Arabic speakers\n\n\\-\n\nExclusion Criteria:\n\n* severe dementia, delirium, major mental disorders, aphasia, and those with severe visual or hearing impairment that interfere with the assessment.'}, 'identificationModule': {'nctId': 'NCT06789094', 'acronym': 'ASCA', 'briefTitle': 'Validating the Ain Shams Cognitive Assessment Tool', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Validating the Ain Shams Cognitive Assessment (ASCA) for Diagnosing Mild Cognitive Impairment and Dementia', 'orgStudyIdInfo': {'id': 'FMASU R310/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dementia', 'description': 'participants \\>60 years with Dementia diagnosed by DSM-5 criteria', 'interventionNames': ['Other: Ain Shams University Cognitive Assessment (ASCA) tool']}, {'label': 'Mild cognitive impairment', 'description': 'participants \\>60 years with Mild cognitive impairment (MCI) diagnosed by DSM-5 criteria', 'interventionNames': ['Other: Ain Shams University Cognitive Assessment (ASCA) tool']}, {'label': 'control', 'description': 'euthymic healthy community dwelling adult participants of various socioeconomic and educational status.', 'interventionNames': ['Other: Ain Shams University Cognitive Assessment (ASCA) tool']}], 'interventions': [{'name': 'Ain Shams University Cognitive Assessment (ASCA) tool', 'type': 'OTHER', 'otherNames': ['Patient Health Questionnaire 9', 'activity of daily living questionnaire'], 'description': 'The ASCA, developed at Ain Shams University, is a comprehensive tool designed for cognitive assessment in Egyptian population. It encompasses various tests to assess cognitive functions and cultural understanding. These include the Verbal Paired Associated Test, evaluating verbal learning, distractor interval, delayed recall, and word recognition. The Bender Gestalt assesses visual-motor skills and memory. Short-term and working memory are tested through Digit Forward and Digit Backward Span Length tasks. Set Shifting is measured using a modified Trail Making Test, adapted for illiterates. Additionally, tests for letter/lexical fluency, verbal fluency, language object naming, abstraction, and judgment offer further insights into cognitive abilities and cultural interpretation.', 'armGroupLabels': ['Dementia', 'Mild cognitive impairment', 'control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Doha Rasheedy, Professor', 'role': 'CONTACT', 'email': 'doharasheedy@med.asu.edu.eg', 'phone': '01001193544', 'phoneExt': '202'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Geriatrics and Gerontology', 'investigatorFullName': 'Doha Rasheedy', 'investigatorAffiliation': 'Ain Shams University'}}}}