Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT02759159
Status:
UNKNOWN
Last Update Posted:
2016-10-05
First Post:
2016-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-04', 'studyFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'brain functional connectivity', 'timeFrame': 'with in first week after the whole acupuncture treatment', 'description': 'GE750 3.0T gradient-echo single-shot echo plannar imaging TR=2000ms TE=30ms slice=36 slice thickness=3mm gap=1mm volumes=180'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "Alzheimer's disease (AD) is one of the major brain diseases which received more attention in recent years. The disconnection syndrome is the main pathophysiological mechanism leading to cognitive decline in AD patients. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on AD patients by moderating the neural pathway directly. However, the underlying mechanism remains unclear. By using resting state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and neurology sciences, investigators will explore the multi-modality data analysis; compare brain connectivity and network parameters changes between pre- and post- acupuncture treatment; analyze the correlation between fMRI changes and neuropsychology test. The present study aims to elucidate the neural mechanism of acupuncture therapy on early AD, provide theoretical evidence from the perspective of functional connectivity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nClinical diagnosis of Alzheimer's Disease Clinical diagnosis of MCI due to Alzheimer's Disease Drug therapy regularly\n\nExclusion Criteria:\n\nFrontotemporal dementia Lewy body dementia Vascular dementia Severe depression Brain vascular disease Metabolic disease"}, 'identificationModule': {'nctId': 'NCT02759159', 'briefTitle': "The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI", 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'The Study of Brain Functional Network Modulatory Mechanism of Alzheimer\'s Disease Using Acupuncture at the "Four-gate" Acupoints', 'orgStudyIdInfo': {'id': '81471649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AD-true acupuncture', 'description': 'True acupuncture at the "four-gate"acupoints will be administered on AD patients', 'interventionNames': ['Procedure: true acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'AD-sham acupuncture', 'description': 'Sham acupuncture at the "four-gate"acupoints will be administered on AD patients', 'interventionNames': ['Procedure: sham acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Cognitive Impairment(MCI)-true acupuncture', 'description': 'True acupuncture at the "four-gate"acupoints will be administered on MCI patients', 'interventionNames': ['Procedure: true acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'MCI-sham acupuncture', 'description': 'Sham acupuncture at the "four-gate"acupoints will be administered on MCI patients', 'interventionNames': ['Procedure: sham acupuncture']}], 'interventions': [{'name': 'true acupuncture', 'type': 'PROCEDURE', 'description': 'acupuncture at the "four-gate"acupoints, three times per week and last for 6 months', 'armGroupLabels': ['AD-true acupuncture', 'Mild Cognitive Impairment(MCI)-true acupuncture']}, {'name': 'sham acupuncture', 'type': 'PROCEDURE', 'description': 'acupuncture at the places 1cm from the true "four-gate "acupoints,three times per week and last for 6 months', 'armGroupLabels': ['AD-sham acupuncture', 'MCI-sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Li', 'role': 'CONTACT', 'email': '810009062@qq.com'}], 'facility': 'Xuanwu hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ran Pang, Doctor', 'role': 'CONTACT', 'email': 'pangrandf@163.com', 'phone': '+8613693121651'}], 'facility': 'Dongfang Hospital,Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kuncheng Li, Doctor', 'role': 'CONTACT', 'email': 'cjr.likuncheng@vip.163.com', 'phone': '+861083198376'}, {'name': 'Hui Li', 'role': 'CONTACT', 'email': '810009062@qq.com', 'phone': '+861083198376'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Radiology Department', 'investigatorFullName': 'likuncheng', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}