- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02837705
Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers (PRNP)
May 23, 2023 updated by: University of Zurich
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
213
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Graz, Austria
- Medical University Graz
-
-
-
-
-
Göttingen, Germany
- University Medical Center Göttingen
-
-
-
-
-
Pardés H̱anna Karkur, Israel
- CJD Foundation Israel
-
-
-
-
-
Milano, Italy
- Istituto di Ricerche Farmacologiche
-
-
-
-
-
Bratislava, Slovakia
- Slovak Medical University
-
-
-
-
-
Zürich, Switzerland
- Institute of Neuropathology
-
-
-
-
California
-
San Francisco, California, United States
- UCSF Memory and Aging Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Male or female carriers of a mutation in the Prion protein gene of any age and their wild type siblings.
Description
Inclusion Criteria:
- Relatives of patients of genetic Prion diseases
- Obtained informed consent
Exclusion Criteria:
- No informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
carriers of a mutation in the Prion gene
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.
|
|
family members of carriers of a mutation in the Prion gene
Relatives of confirmed PrP mutation carriers who carry two wild type alleles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anti-Prion protein autoantibody levels
Time Frame: Baseline, up to 90 years
|
Baseline, up to 90 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
October 15, 2018
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
July 7, 2016
First Submitted That Met QC Criteria
July 14, 2016
First Posted (Estimate)
July 20, 2016
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 23, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0514
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prion Diseases
-
Ionis Pharmaceuticals, Inc.RecruitingPrion DiseaseUnited States, Spain, Israel, Japan, Germany, Canada
-
Medical Research CouncilCompleted
-
University of EdinburghNHS Lothian; Department of Health, United KingdomUnknown
-
Sheba Medical CenterProf. Zerr , Prion Referral Center , University of Gottingen, GermanyNot yet recruitingCreutzfeldt-Jakob Syndrome
-
Massachusetts General HospitalBroad InstituteRecruitingPrion Diseases | Familial Fatal Insomnia | CJD (Creutzfeldt Jakob Disease) | GSS | FFIUnited States
-
Peking University Third HospitalCenters for Disease Control and Prevention, ChinaCompletedCreutzfeldt Jakob Disease
-
Tel-Aviv Sourasky Medical CenterRecruitingCreutzfeldt-Jakob Disease (CJD)Israel
-
University of California, San FranciscoNational Institute on Aging (NIA)Completed
-
Mario Negri Institute for Pharmacological ResearchFondazione TelethonCompleted
-
Kantonsspital AarauNovartis; University Hospital, Basel, Switzerland; Clinical Trial Unit, University...TerminatedCancer CachexiaSwitzerland
Clinical Trials on blood draw
-
Abbott Point of CareNot yet recruitingPrecision of Potassium (K) Test in Capillary Whole Blood
-
University Hospital, Strasbourg, FranceNot yet recruitingKidney Transplantation | Humoral Rejection | Kidney Allograft Biopsy | Microvascular Inflammation
-
Vanderbilt-Ingram Cancer CenterWren Laboratories LLCCompletedMelanomaUnited States
-
Turtle Health, Inc.Completed
-
National Heart Centre SingaporeDuke-NUS Graduate Medical SchoolRecruiting
-
Duke UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)RecruitingHematologic MalignancyUnited States
-
University of BonnRecruitingSARS-CoV 2 | COVIDGermany
-
Joseph M. Still Research Foundation, Inc.RecruitingInflammatory Response | Deep Vein Thrombosis | Multi Organ Failure | Nosocomial InfectionUnited States
-
Northwestern UniversityRecruiting