Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-29 @ 5:31 PM
Study NCT ID:
NCT01823666
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2013-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting the Conversion From Mild Cognitive Impairment to Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'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'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2013-03-30', 'studyFirstSubmitQcDate': '2013-04-03', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of conversion to dementia', 'timeFrame': 'At baseline, 26 weeks, and 52 weeks.'}], 'secondaryOutcomes': [{'measure': 'Mini-Mental State Examination', 'timeFrame': 'At baseline, 26 weeks, and 52 weeks'}, {'measure': 'Immediate and delayed story recall', 'timeFrame': 'At baseline, 26 weeks, and 52 weeks'}, {'measure': 'Clock Drawing Test(CDT)', 'timeFrame': 'At baseline, 26 weeks, and 52 weeks'}, {'measure': 'Boston Naming Test', 'timeFrame': 'At baseline, 26 weeks, and 52 weeks'}, {'measure': 'Verbal Category Fluency Test(animals)', 'timeFrame': 'At baseline, 26 weeks, and 52 weeks'}, {'measure': 'Trail Making Test(TMT)', 'timeFrame': 'At baseline, 26 weeks, and 52 weeks'}, {'measure': 'Hopkins Verbal Learning Test(HVLT)', 'timeFrame': 'At baseline, 26 weeks, and 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dementia', "Alzheimer's disease", 'mild cognitive impairment'], 'conditions': ['Mild Cognitive Impairment', 'Alzheimer Disease', 'Dementia, Vascular']}, 'referencesModule': {'references': [{'pmid': '26172064', 'type': 'DERIVED', 'citation': 'Ni J, Shi J, Wei M, Tian J, Jian W, Liu J, Liu T, Liu B. Screening mild cognitive impairment by delayed story recall and instrumental activities of daily living. Int J Geriatr Psychiatry. 2015 Aug;30(8):888-90. doi: 10.1002/gps.4317. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The investigators assume that some psychological and imaging risks may predict the conversion. In the current longitudinal study, psychological and imaging data of people with MCI will be obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be found in comparison with controls.', 'detailedDescription': "MCI increases the risk of later developing dementia. About 10-15% of the amnestic form of mild cognitive impairment will progress to Alzheimer's disease in one year. But some people with MCI never get worse. Others with MCI later have test results that return to normal for their age and education.\n\nTo develop a new drug for the prevention of dementia(dementia due to Alzheimer's disease or vascular dementia), investigators need a sensitive and specific tool for recognizing patients who will converse to dementia. The investigators want to establish an operational diagnostic criteria instead of a descriptive criteria for mild cognitive impairment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with cognitive complaint living in the community.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* complaint about cognitive decline compared to previous performance\n* objective cognitive impairment in one or more cognitive domains for age\n* preservation of independence in functional abilities\n* Mini-Mental State Examination(MMSE) scores between 24 and 30\n* a Clinical Dementia Rating(CDR) score of 0.5\n\nExclusion Criteria:\n\n* dementia\n* patient with any following disease: Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy\n* depression(HAMD \\>7) or psychosis\n* uncontrolled severe medical conditions(i.e., acute heart failure, renal insufficiency)\n* current treatment with benzodiazepines, antidepressants, antipsychotics, or other medications with significant psychotropic or central cholinergic effects\n* abnormal thyroid, low vitamin B12 level or low folic acid level\n* patient with visual and auditory disorders can't cooperate with neuropsychological assessment\n* patient can't cooperate with following up\n* informed consent is not obtained"}, 'identificationModule': {'nctId': 'NCT01823666', 'acronym': 'PCMCItoD', 'briefTitle': 'Predicting the Conversion From Mild Cognitive Impairment to Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Dongzhimen Hospital, Beijing'}, 'officialTitle': 'Study on Risk Factors for Prediction of Conversion to Dementia in Patients With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'Z11107056811043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild cognitive impairment', 'description': 'People with cognitive complaint will be recruited. Who can be diagnosed as mild cognitive impairment will be enrolled according to the MCI criteria.'}, {'label': 'Control', 'description': 'Normal cognition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jinzhou Tian, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongzhimen Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongzhimen Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jinzhou Tian', 'investigatorAffiliation': 'Dongzhimen Hospital, Beijing'}}}}