Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 8:54 PM
Study NCT ID:
NCT07324161
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2025-12-24', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MoCA Changes from baseline to post-treatment', 'timeFrame': 'Baseline vs 2 weeks and 6 months after treatment', 'description': 'Montreal Cognitive Assessment (MoCA)'}], 'secondaryOutcomes': [{'measure': 'CDR Changes from baseline to post-treatment', 'timeFrame': 'Baseline vs 2 weeks and 6 months after treatment', 'description': 'Clinical Dementia Rating (CDR)'}, {'measure': 'MMSE Changes from baseline to post-treatment', 'timeFrame': 'Baseline vs 2 weeks and 6 months after treatment', 'description': 'Mini-Mental State Examination (MMSE)'}, {'measure': 'NPI Changes from baseline to post-treatment', 'timeFrame': 'Baseline vs 2 weeks and 6 months after treatment', 'description': 'Neuropsychiatric Inventory (NPI)'}, {'measure': 'Neuropathological markers Change from baseline to post-treatment', 'timeFrame': 'Baseline vs 2 weeks and 6 months after treatment', 'description': 'Aβ, tau, GFAP, NFL, VEGF'}, {'measure': 'TMS-EEG Changes from baseline to post-treatment', 'timeFrame': 'Baseline vs 2 weeks and 6 months after treatment', 'description': 'Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer s Disease']}, 'descriptionModule': {'briefSummary': "This study is grounded in the regulatory mechanisms of the glymphatic system and applies repetitive transcranial magnetic stimulation (rTMS) to the treatment of Alzheimer's disease (AD). The clinical efficacy and safety of rTMS will be systematically evaluated. Furthermore, transcranial magnetic stimulation-evoked potentials (TMS-EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to investigate, from the perspectives of synaptic plasticity and neurovascular coupling, the mechanisms by which rTMS influences glymphatic function. Collectively, this work aims to provide new insights into both the therapeutic effectiveness and the underlying mechanisms of rTMS in AD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets the 2018 NIA-AA diagnostic criteria for Alzheimer's disease (AD)\n* Meets DSM-5 diagnostic criteria\n* Mild to moderate disease severity (CDR Global Score 1 to 2)\n* Evidence of AD pathology: positive amyloid PET OR positive cerebrospinal fluid (CSF) AD biomarkers OR positive plasma AD biomarkers\n\nExclusion Criteria:\n\n* Contraindications to rTMS treatment\n* Severe complications or immune diseases\n* Unable to cooperate with study procedures\n* History of epilepsy"}, 'identificationModule': {'nctId': 'NCT07324161', 'briefTitle': "Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': "Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in the Treatment of Alzheimer's Disease and Exploration of Glymphatic Mechanisms", 'orgStudyIdInfo': {'id': 'rTMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rTMS', 'interventionNames': ['Device: rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham rTMS', 'interventionNames': ['Device: sham rTMS']}], 'interventions': [{'name': 'rTMS', 'type': 'DEVICE', 'description': 'Stimulation coil Cool-B65 A CO, positioning individualised, stimulation frequency 20Hz, stimulation intensity 100% of motor threshold, stimulation number 40 pulses/train, train interval 28s, 40 trains, 1600 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week.Consolidation therapy was also administered weekly for 6 months.', 'armGroupLabels': ['rTMS']}, {'name': 'sham rTMS', 'type': 'DEVICE', 'description': 'Stimulation coil Cool-B65 P CO, positioning individualised, stimulation frequency 20Hz, stimulation intensity 100% of motor threshold, stimulation number 40 pulses/train, train interval 28s, 40 trains, 1600 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week', 'armGroupLabels': ['sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaodong Pan', 'role': 'CONTACT', 'email': 'panxd@fjmu.edu.cn', 'phone': '059186218340'}], 'facility': 'rTMS', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Xiaodong Pan', 'role': 'CONTACT', 'email': 'panxd@fjmu.edu.cn', 'phone': '13395080173'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}