Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2025-12-30 @ 3:32 PM
Study NCT ID:
NCT05055895
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Anticholinergic Burden With Onset of Delirium in Older Adults With Alzheimer Dementia:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-15', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time onset of delirium superimposed dementia', 'timeFrame': '12 month', 'description': 'First attack of delirium onset'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Anticholinergic Adverse Reaction', 'Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'Drugs with anticholinergic properties are commonly prescribed to older persons despite growing evidence of their significant adverse effects. However, limited data are available concerning their contribution to time of onset of delirium. This study aimed to determine the potential association of higher anticholinergic burden to early-onset of delirium superimposed dementia in the older adult.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participiants enrolled from outpaitent clinic and underwent by comprehesive geriatric asssessment.\n\nDelirium and dementia status was assessed by the criteria of confusion assessment method (CAM) and DSM-4 or DSM-5 respectively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years and older and diagnosis or fellow-up of Alzhemier dementia in outpatient clinic.\n\nExclusion Criteria:\n\n* The patients with a history of other than Alzhemier dementia or neurodegenerative disease (epilepsy, multiple sclerosis, Parkinson disease, etc.), terminal illness (malignancy, advanced organ failure) were excluded.'}, 'identificationModule': {'nctId': 'NCT05055895', 'briefTitle': 'Association of Anticholinergic Burden With Onset of Delirium in Older Adults With Alzheimer Dementia:', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gulhane Training and Research Hospital'}, 'officialTitle': 'Association of Anticholinergic Burden With Onset of Delirium in Older Adults With Alzheimer Dementia: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '2020-383'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'early onset deliryum on dementia', 'description': 'It was earlier than The median time of onset of delirium superimposed dementia', 'interventionNames': ['Drug: Anticholinergic burden']}, {'label': 'Delirium on dementia (normal)', 'description': 'It was equal or later than The median time of onset of delirium superimposed dementia', 'interventionNames': ['Drug: Anticholinergic burden']}], 'interventions': [{'name': 'Anticholinergic burden', 'type': 'DRUG', 'description': 'The anticholinergic burden (ACB) was assessed using the Anticholinergic Burden Scale.\n\nHigher ACB was described as equal or higher than 1.', 'armGroupLabels': ['Delirium on dementia (normal)', 'early onset deliryum on dementia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06670', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Bilal Katipoglu, MD', 'role': 'CONTACT', 'email': 'drbilal07@gmail.com', 'phone': '+905543330380'}, {'name': 'Mehmet I Naharcı, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gulhane training and research hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Geriatric', 'investigatorFullName': 'Bilal Katipoglu', 'investigatorAffiliation': 'Gulhane Training and Research Hospital'}}}}