Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
PRNP
1 other identifier
observational
213
7 countries
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 24, 2023
May 1, 2023
3.1 years
July 7, 2016
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Anti-Prion protein autoantibody levels
Baseline, up to 90 years
Study Arms (2)
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.
Interventions
Eligibility Criteria
Male or female carriers of a mutation in the Prion protein gene of any age and their wild type siblings.
You may qualify if:
- Relatives of patients of genetic Prion diseases
- Obtained informed consent
You may not qualify if:
- No informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
UCSF Memory and Aging Center
San Francisco, California, United States
Medical University Graz
Graz, Austria
University Medical Center Göttingen
Göttingen, Germany
CJD Foundation Israel
Pardés H̱anna Karkur, Israel
Istituto di Ricerche Farmacologiche
Milan, Italy
Slovak Medical University
Bratislava, Slovakia
Institute of Neuropathology
Zurich, Switzerland
Related Publications (1)
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.
PMID: 32098855DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2016
First Posted
July 20, 2016
Study Start
September 1, 2015
Primary Completion
October 15, 2018
Study Completion
March 1, 2019
Last Updated
May 24, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share