Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT05014893
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2021-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2021-08-01', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Up to 24 months.', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.'}], 'primaryOutcomes': [{'measure': 'Change in Cognitive function (SCD-9)', 'timeFrame': 'Change from Baseline Cognitive test results at 3 months.', 'description': 'The SCD-9 questionnaire is used to assess cognitive function of participants.'}, {'measure': 'Change in Cognitive function (MoCA)', 'timeFrame': 'Change from Baseline Cognitive test results at 3 months.', 'description': 'The Montreal Cognitive Assessment test is used to assess cognitive function of participants.'}, {'measure': 'Change in Cognitive function (AD8)', 'timeFrame': 'Change from Baseline Cognitive test results at 3 months.', 'description': 'The AD8 test is used to assess cognitive function of participants.'}, {'measure': 'Change in Cognitive function (CDR)', 'timeFrame': 'Change from Baseline Cognitive test results at 3 months.', 'description': 'The Clinical Dementia Rating (CDR) test is used to assess cognitive function of participants.'}], 'secondaryOutcomes': [{'measure': 'Change in Physical capacity (TUG)', 'timeFrame': 'Change from Baseline physical capacity test results at 3 months.', 'description': 'The timed up and go (TUG) test is used to evaluate physical capacity of participants.'}, {'measure': 'Change in Physical capacity (chair standing)', 'timeFrame': 'Change from Baseline physical capacity test results at 3 months.', 'description': 'The 30-second chair standing test is used to evaluate physical capacity of participants.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment (MCI)', 'Subjective Cognitive Decline (SCD)', 'Aging', 'Healthy']}, 'descriptionModule': {'briefSummary': 'This study investigates the neural mechanisms of cognitive function decline, cognitive assessment methods for subjects with mild cognitive dysfunction (Mild cognitive impairment, MCI, or cognitive decline milder than MCI), and the approaches used to improve and restore cognitive function.', 'detailedDescription': 'Cognitive assessment tools are used to assess cognitive function of subjects in different cities. Functional and structural MRI and EEG are applied to investigate the neural mechanisms of cognitive function decline and effects of methods to improve and restore cognitive function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults being able to walk at least a block, and\n* Adults with subjective cognitive decline (SCD), or\n* Adults with mild cognitive impairment (MCI), or\n* Adults with normal cognitive function\n\nExclusion Criteria:\n\n* Clinical diagnosis of dementia\n* Adults who cannot follow the protocal'}, 'identificationModule': {'nctId': 'NCT05014893', 'briefTitle': 'Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline', 'organization': {'class': 'OTHER', 'fullName': 'National Research Center for Rehabilitation Technical Aids'}, 'officialTitle': 'Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline', 'orgStudyIdInfo': {'id': '201900045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group, without specific treatments'}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive training', 'description': 'This group receives treatments to improve cognitive function.', 'interventionNames': ['Combination Product: multi-modal targeted intervention (e.g., cognitive training, exercise, games)']}], 'interventions': [{'name': 'multi-modal targeted intervention (e.g., cognitive training, exercise, games)', 'type': 'COMBINATION_PRODUCT', 'description': 'The Intervention group will be given recommended interventions tailored to individuals based on their risks (e.g., physical exercise programs, cognitive training, dietary advice, control of blood pressure and cholesterol, healthy diet, control obesity, stop smoking,reduce alcohol excess)', 'armGroupLabels': ['Cognitive training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100176', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Wang', 'role': 'CONTACT', 'phone': '1059122921'}], 'facility': 'National Research Center for Rehabilitation Technical Aids', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ying Wang', 'role': 'CONTACT', 'email': 'CARM_AD@aliyun.com', 'phone': '1058122921'}], 'overallOfficials': [{'name': 'Pengxu Wei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Center for Rehabilitation Technical Aids'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Center for Rehabilitation Technical Aids', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing Brain Hospital', 'class': 'UNKNOWN'}, {'name': "The Third People's Hospital of Yunnan Province", 'class': 'OTHER_GOV'}, {'name': 'Central South University', 'class': 'OTHER'}, {'name': 'Beijing academy of science and technology', 'class': 'UNKNOWN'}, {'name': 'Beijing University of Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Pengxu Wei', 'investigatorAffiliation': 'National Research Center for Rehabilitation Technical Aids'}}}}