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Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers (PRNP)

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ClinicalTrials.gov Identifier: NCT02837705
Recruitment Status : Unknown
Verified December 2018 by University of Zurich.
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2016
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date July 7, 2016
First Posted Date July 20, 2016
Last Update Posted Date December 7, 2018
Study Start Date September 2015
Actual Primary Completion Date October 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2016)
Anti-Prion protein autoantibody levels [ Time Frame: Baseline, up to 90 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
Official Title Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
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.
Condition Prion Diseases
Intervention Other: blood draw
Study Groups/Cohorts
  • 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.
    Intervention: Other: blood draw
  • family members of carriers of a mutation in the Prion gene
    Relatives of confirmed PrP mutation carriers who carry two wild type alleles.
    Intervention: Other: blood draw
Publications * Frontzek K, Carta M, Losa M, Epskamp M, Meisl G, Anane A, Brandel JP, Camenisch U, Castilla J, Haïk S, Knowles T, Lindner E, Lutterotti A, Minikel EV, Roiter I, Safar JG, Sanchez-Valle R, Žáková 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: December 6, 2018)
213
Original Estimated Enrollment
 (submitted: July 14, 2016)
500
Estimated Study Completion Date March 2019
Actual Primary Completion Date October 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Relatives of patients of genetic Prion diseases
  • Obtained informed consent

Exclusion Criteria:

  • No informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Germany,   Israel,   Italy,   Slovakia,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02837705
Other Study ID Numbers 2015-0514
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Zurich
Verification Date December 2018