Prion DiseasesPRNPNCT02837705
Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
An observational study of Prion Diseases, run by University of Zurich at 7 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Prion Diseases
- What is being tested?
- blood draw
- How many people
- 213 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 1 Sep 2015to 1 Mar 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Male or female carriers of a mutation in the Prion protein gene of any age and their wild type siblings.
Who may be able to join
- Relatives of patients of genetic Prion diseases
- Obtained informed consent
Who cannot join
- No informed consent
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
UCSF Memory and Aging Center
San Francisco, California
About this study
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.
- Conditions
- Prion Diseases
- Being tested
- blood draw
- Medical subject headings
- Prion Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Prion protein autoantibody levels
Measured: Baseline, up to 90 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start1 Sep 2015
- Primary completion15 Oct 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prion DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 213 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837705
- Sponsor's protocol ID
- 2015-0514
- Acronym
- PRNP
- Status last verified
- May 2023
- First submitted
- 7 Jul 2016
- Last updated
- 24 May 2023
- Results posted
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32098855
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
- ClinicalTrials.gov ID
- NCT02837705
- Acronym / sponsor ID
- PRNP / 2015-0514
- Conditions
- Prion Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carriers of a mutation in the Prion gene | – | Other: blood drawCarriers 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 | – | Other: blood drawRelatives of confirmed PrP mutation carriers who carry two wild type alleles. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female carriers of a mutation in the Prion protein gene of any age and their wild type siblings.
Key inclusion criteria (2 listed)
- Relatives of patients of genetic Prion diseases
- Obtained informed consent
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw | Other | carriers of a mutation in the Prion gene, family members of carriers of a mutation in the Prion gene |
Primary outcome
Anti-Prion protein autoantibody levels
Time frame: Baseline, up to 90 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 32098855Frontzek 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prion Diseases, run by University of Zurich at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Austria, Germany, Israel, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Prion protein autoantibody levels (time frame: Baseline, up to 90 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.