Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-10 @ 9:38 AM
Study NCT ID:
NCT03119051
Status:
UNKNOWN
Last Update Posted:
2020-08-17
First Post:
2017-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-14', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of AD', 'timeFrame': '12 months', 'description': 'The 3-year incidence of AD in each group will be compared.'}], 'secondaryOutcomes': [{'measure': 'The global cognitive function of MCI patients', 'timeFrame': '6 months', 'description': 'Alzheimer disease assessment scale (ADAS-Cog) will be used to assess the global cognitive performance of MCI patients'}, {'measure': 'Memory', 'timeFrame': '12 months', 'description': 'Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).'}, {'measure': 'Attention', 'timeFrame': '12 months', 'description': 'Attention will be evaluated by Trial Making Test (TMT).'}, {'measure': 'Executive functions', 'timeFrame': '12 months', 'description': 'Executive functions will be evaluated by the Stroop task.'}, {'measure': 'Language', 'timeFrame': '12 months', 'description': 'Language will be assessed by Boston naming test (30-item version).'}, {'measure': 'Visual spatial ability and visual memory', 'timeFrame': '12 months', 'description': 'Visual spatial ability and visual memory will be evaluated by the Rey-Osterrieth complex figure test (CFT).'}, {'measure': 'Activities of daily living', 'timeFrame': '6 months', 'description': "Activities of daily living will be assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)."}, {'measure': 'Structural MRI', 'timeFrame': '12 months', 'description': 'Volume of hippocampus and other specific brain regions'}, {'measure': 'Gut microbiota', 'timeFrame': '12 months', 'description': 'Number of genera and abundence of E.coli in feces and blood'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mild cognitive impairment'], 'conditions': ['Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '30041656', 'type': 'DERIVED', 'citation': 'Lin Y, Li B, Tang H, Xu Q, Wu Y, Cheng Q, Li C, Xiao S, Shen L, Tang W, Yu H, He N, Lin H, Yan F, Cao W, Yang S, Liu Y, Zhao W, Lu D, Jiao B, Xiao X, Zhou L, Chen S. Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology. BMC Neurol. 2018 Jul 24;18(1):103. doi: 10.1186/s12883-018-1100-x.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of "computerized cognitive training" and "cognitive training plus exercise training" on different cognitive domains in mild cognitive impairment (MCI) patients. Patients will be randomized into the computerized training group, cognitive training plus exercise training group and the control group.', 'detailedDescription': 'Mild cognitive impairment (MCI) is an early stage of Alzheimer Disease (AD). Increasing evidence has indicated that cognitive trainings improve cognition functions of MCI patients in multiple cognitive domains, making it a promising therapy for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent of its function in reducing the conversion rate from MCI to AD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, aged 50-85;\n* MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups\\[1\\];\n* 24≤Mini-Mental State Examination (MMSE) ≤28；\n* The Hamilton Depression Scale/17-item (HAMD) score ≤10;\n* Not on medication for dementia;\n* MRI T2 weighted image (T2WI) scan: aged ≤70 , Fazeca scale for White Matter lesions rating level≤1; \\>70 years, white matter damage rating scale ≤2. The number of lacunar infarcts larger than 2 cm in diameter ≤2. No infarcts in hypothalamus, entorhinal cortex, para-hypothalamus, cortical and subcortical cavity infarction near gray matter nuclei. The medial temporal lobe atrophy (MTA) score: Grade II or above.\n* Accompanied by reliable caregivers (at least intensive contact of 4 days every week and 2 hours every day) who are expected to participate in the follow-up visits and provide useful information for scores of scales like ADCS-ADL;\n* Education level: primary school (grade 6) or above.\n* Expected good compliance with the therapy and follow-up. Each patient gives a written informed consent, and the study has been approved by Ruijin Hospital's ethical committees.\n\nExclusion Criteria:\n\n* Cognitive decline caused by other diseases (cerebrovascular disease, central nervous system infections, Parkinson's disease, metabolic encephalopathy, intracranial space-occupying lesions, deficiency of folic acid/vitamin B12 and hypothyroidism);\n* Medical history of other neurological disorders (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.);\n* Psychiatric disorders defined by (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria;\n* Unstable or severe disease of heart, lung, liver, kidney or hematopoietic system;\n* History of alcohol or drug abuse;\n* Participation in other clinical trial less than 30 days before the screening of this study;\n* Inability to complete the study."}, 'identificationModule': {'nctId': 'NCT03119051', 'acronym': 'SIMPLE', 'briefTitle': 'Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation', 'orgStudyIdInfo': {'id': 'RuijinHSH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'online cognitive training', 'description': "Patients will receive 3-4 times of 20-30 minutes' training game every week", 'interventionNames': ['Behavioral: Online cognitive training']}, {'type': 'NO_INTERVENTION', 'label': 'no training', 'description': 'Patients will not undergo preoperative cognitive training.'}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive training and physical exercise', 'description': "Patients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training", 'interventionNames': ['Behavioral: Cognitive training plus physical exercise']}], 'interventions': [{'name': 'Online cognitive training', 'type': 'BEHAVIORAL', 'description': "A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.", 'armGroupLabels': ['online cognitive training']}, {'name': 'Cognitive training plus physical exercise', 'type': 'BEHAVIORAL', 'description': "Online cognitive training A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.\n\nPhysical Exercise Tai Chi Training：a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction.", 'armGroupLabels': ['Cognitive training and physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200002', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Binyin Li, Dr', 'role': 'CONTACT', 'email': 'libinyin@126.com', 'phone': '86-13681884221'}, {'name': 'Yiqi Lin, Dr', 'role': 'CONTACT', 'email': 'linyiqi@126.com', 'phone': '86-021-64454473'}], 'facility': 'Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Sheng-Di Chen', 'role': 'CONTACT', 'email': 'chen_sd@medmail.com.cn', 'phone': '86-21-6445-4473'}], 'overallOfficials': [{'name': 'Sheng-Di Chen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Binyin Li', 'investigatorAffiliation': 'Ruijin Hospital'}}}}