Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-08 @ 8:56 PM
Study NCT ID:
NCT02109705
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2014-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Porphyromonas Gingivalis and Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'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'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'GCF, Liquor, Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cmax: Periodontal pathogens', 'timeFrame': 'Baseline', 'description': 'laboratory analysis'}, {'measure': 'U enzyme activities', 'timeFrame': 'Baseline', 'description': 'laboratory analysis'}, {'measure': 'Cmax: inflammatory cytokines', 'timeFrame': 'Baseline', 'description': 'laboratory analysis'}], 'primaryOutcomes': [{'measure': 'Cmax Antibody Levels against Gingipains', 'timeFrame': 'Baseline', 'description': 'laboratory analysis'}], 'secondaryOutcomes': [{'measure': 'Cmax Beta-Amyloid', 'timeFrame': 'Baseline', 'description': 'laboratory analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease", 'Dementia', 'Periodontitis']}, 'descriptionModule': {'briefSummary': "With this study the investigators would like to analyze the the role of periodontal disease and especially the role of Porphyromonas gingivalis in initiation and progression of Alzheimer's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "60 Patients with Dementia (30 with Alzheimer's and 30 with another Dementia) 30 cognitive healthy patients", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 40-70\n* caucasian origin\n* dementia (Alzheimer's or other dementia)\n* cognitive healthy (need for spinal anesthesia)\n\nExclusion Criteria:\n\n* use of antibiotics within las 6 months\n* pregnancy\n* another illness explaining the symptoms in a better way\n* smoking (\\>10 cigarettes)\n* patients who have a legal custodian"}, 'identificationModule': {'nctId': 'NCT02109705', 'acronym': 'PGNEURO', 'briefTitle': "Porphyromonas Gingivalis and Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': "Porphyromonas Gingivalis - a Responsible Pathogen in Alzheimer's Disease?", 'orgStudyIdInfo': {'id': 'PG001'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Alzheimer's Disease"}, {'label': 'other Dementia'}, {'label': 'cognitive healthy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48143', 'city': 'Münster', 'country': 'Germany', 'facility': 'Department of Periodontology', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Oliver Laugisch, Dr med dent MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Periodontology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}