Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT06920212
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy endpoints', 'timeFrame': '0, 1month, 2months, 3months, 6months', 'description': "Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)"}, {'measure': 'Efficacy endpoints', 'timeFrame': '0, 1month, 2months, 3months, 6months', 'description': 'Changes in scores on Mini-Mental State Examination (MMSE).'}, {'measure': 'Efficacy endpoints', 'timeFrame': '0, 1month, 2months, 3months, 6months', 'description': "Changes in scores on Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADAS-CGIC)."}, {'measure': 'Efficacy endpoints', 'timeFrame': '0, 1month, 2months, 3months, 6months', 'description': "Changes in scores on Alzheimer's Disease Activities of Daily Living Scale (ADAS-ADL)"}, {'measure': 'Changes in gut microbiota', 'timeFrame': '0, 1month, 2months, 3month, 6months', 'description': "Gut metagenomic sequencing was performed to conduct OTU (Operational Taxonomic Unit) clustering and taxonomic analysis, comparing alterations in patients' intestinal flora before and after FMT."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fecal Microbiota Transplantation']}, 'descriptionModule': {'briefSummary': 'To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patients (aged 50-85 years) exhibited cognitive decline persisting for over six months;\n* Primarily characterized by recent memory impairment and accompanied by reduced daily living abilities;\n* MMSE scores ranging from 3 to 26;\n* MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures.\n\nExclusion Criteria:\n\n* Patients were excluded if they had severe visual, hearing, or language impairments;\n* Tumors;\n* hepatic/renal dysfunction.\n* with conditions mimicking AD symptoms-such as normal pressure hydrocephalus, vascular dementia (VD or VaD);\n* Parkinson's disease dementia (PDD)-were also excluded;\n* patients who had participated in clinical drug trials within the past 30 days or consumed folate and vitamin B12 at doses exceeding twice the recommended intake were ineligible."}, 'identificationModule': {'nctId': 'NCT06920212', 'briefTitle': "Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': "Clinical Safety and Efficacy of FMT in the Treatment of Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'FMT-AD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMT', 'interventionNames': ['Procedure: FMT capsule']}], 'interventions': [{'name': 'FMT capsule', 'type': 'PROCEDURE', 'description': 'Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota. Its basic principle involves extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota.', 'armGroupLabels': ['FMT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Le Wang', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dean of the hospital', 'investigatorFullName': 'Huanlong Qin', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}