Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-28 @ 2:11 PM
Study NCT ID:
NCT02837705
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2016-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017096', 'term': 'Prion Diseases'}], 'ancestors': [{'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-Prion protein autoantibody levels', 'timeFrame': 'Baseline, up to 90 years'}]}, 'conditionsModule': {'conditions': ['Prion Diseases']}, 'referencesModule': {'references': [{'pmid': '32098855', 'type': 'DERIVED', 'citation': 'Frontzek K, Carta M, Losa M, Epskamp M, Meisl G, Anane A, Brandel JP, Camenisch U, Castilla J, Haik S, Knowles T, Lindner E, Lutterotti A, Minikel EV, Roiter I, Safar JG, Sanchez-Valle R, Zakova D, Hornemann S, Aguzzi A; THAUTAN-MC Study Group. Autoantibodies against the prion protein in individuals with PRNP mutations. Neurology. 2020 Oct 6;95(14):e2028-e2037. doi: 10.1212/WNL.0000000000009183. Epub 2020 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'The human Prion diseases can be classified into sporadic, acquired and inherited forms. Inherited forms usually manifest in higher age so there have to be factors preventing Prion propagation in young mutation carriers. Antibodies against the flexible tail of Prions have been shown to be protective in mice. The investigators intend to screen mutation carriers and controls for the presence of Prion autoantibodies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female carriers of a mutation in the Prion protein gene of any age and their wild type siblings.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relatives of patients of genetic Prion diseases\n* Obtained informed consent\n\nExclusion Criteria:\n\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT02837705', 'acronym': 'PRNP', 'briefTitle': 'Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers', 'orgStudyIdInfo': {'id': '2015-0514'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'carriers of a mutation in the Prion gene', 'description': 'Carriers of a mutation in the Prion gene who are either symptomatic or pre-symptomatic and who do either know or not know their mutation status.', 'interventionNames': ['Other: blood draw']}, {'label': 'family members of carriers of a mutation in the Prion gene', 'description': 'Relatives of confirmed PrP mutation carriers who carry two wild type alleles.', 'interventionNames': ['Other: blood draw']}], 'interventions': [{'name': 'blood draw', 'type': 'OTHER', 'armGroupLabels': ['carriers of a mutation in the Prion gene', 'family members of carriers of a mutation in the Prion gene']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Memory and Aging Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'University Medical Center Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Pardés H̱anna Karkur', 'country': 'Israel', 'facility': 'CJD Foundation Israel', 'geoPoint': {'lat': 32.47408, 'lon': 34.97781}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto di Ricerche Farmacologiche', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Slovak Medical University', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Institute of Neuropathology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}