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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837705
Recruitment Status : Active, not recruiting
First Posted : July 20, 2016
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment
Prion Diseases Other: blood draw

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Study Type : Observational [Patient Registry]
Actual Enrollment : 213 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
Study Start Date : September 2015
Actual Primary Completion Date : October 15, 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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.
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.
Other: blood draw



Primary Outcome Measures :
  1. Anti-Prion protein autoantibody levels [ Time Frame: Baseline, up to 90 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837705


Locations
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United States, California
UCSF Memory and Aging Center
San Francisco, California, United States
Austria
Medical University Graz
Graz, Austria
Germany
University Medical Center Göttingen
Göttingen, Germany
Israel
CJD Foundation Israel
Pardés H̱anna Karkur, Israel
Italy
Istituto di Ricerche Farmacologiche
Milano, Italy
Slovakia
Slovak Medical University
Bratislava, Slovakia
Switzerland
Institute of Neuropathology
Zürich, Switzerland
Sponsors and Collaborators
University of Zurich

Additional Information:

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02837705     History of Changes
Other Study ID Numbers: 2015-0514
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Prion Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs