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

Status

Completed

Conditions

Intervention / Treatment

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.

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

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.

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