Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-29 @ 8:10 AM
Study NCT ID:
NCT05113732
Status:
UNKNOWN
Last Update Posted:
2021-11-09
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Cognition With Functional Mobility in People With Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'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'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Cognitive Assesment (MoCA)', 'timeFrame': 'Baseline', 'description': 'MoCA assesses cognitive skills such as visuospatial / executive functioning, object naming, memory, attention, language, abstraction, orientation. Higher scores reflect the better performance.'}, {'measure': 'Timed Up and Go Test', 'timeFrame': 'Baseline', 'description': 'Timed Up and Go Test measures the level of functional mobility skills and, assess fall risk and balance. The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded. The shorter time reflect the better performance.'}, {'measure': '5 Time Sit to Stand Test', 'timeFrame': 'Baseline', 'description': '5 Time Sit to Stand Test measures the level of functional mobility skills and, assess fall risk and lower extremity strength. The test measures the time taken to stand five times from a sitting position as quickly as possible. The shorter time reflect the better performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Dementia', "Alzheimer's Disease", 'Dementia, Alzheimer Type']}, 'descriptionModule': {'briefSummary': "This study aimed to investigate relationship between cognitive function and functional mobility in Alzheimer's disease.", 'detailedDescription': "Our hypothesis is that the decrease in cognitive function in individuals with Alzheimer's disease is associated with the level of functional mobility. Sociodemographic information of participants will be recorded. Cognition will assessed with Montreal Cognitive Assessment (MoCA), global score and MoCA's visuospatial executive functions, naming, attention, language, abstract thinking, delayed recall, orientation sub-scores will recorded. Functional mobility will assessed Timed Up and Go Test and 5 Times Sit\\&Stand Test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "People with Alzheimer's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with Alzheimer's disease according to the National Institute of --Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,\n* Over 65 years old,\n* Cases who could understand the instructions given in Turkish were included in the study,\n* Having ambulation skill independently or with walking aid.\n\nExclusion Criteria:\n\n* Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,\n* Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,\n* Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),\n* Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study."}, 'identificationModule': {'nctId': 'NCT05113732', 'briefTitle': "Association of Cognition With Functional Mobility in People With Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': "Association of Cognition With Functional Mobility in People With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'IUC-PT'}}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Kübra Nur Menengiç, MSc', 'role': 'CONTACT', 'email': 'kmenengic@gmail.com', 'phone': '+90 05054400987'}, {'name': 'İpek Yeldan, PhD', 'role': 'CONTACT', 'email': 'ipek.yeldan@iuc.edu.tr', 'phone': '+90 0 (212) 866 37 00', 'phoneExt': '43306'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student of PhD', 'investigatorFullName': 'Kübra Nur Menengiç', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}