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Rostock International Parkinson's Disease Study (ROPAD) (ROPAD)

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ClinicalTrials.gov Identifier: NCT03866603
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Centogene AG Rostock

Brief Summary:

Parkinson's disease (PD) is one of the most common neurodegenerative disorders worldwide, affecting approximately 1% of individuals older than 60 years and causes progressive disability.

PD is mostly considered as idiopathic disease, however more and more data suggest that it is a disease that involves interaction of genetic and environmental factors. The most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD.

The aims of this study are the identification of 1,500 LRRK2-positive patients, the identification of 1,500 non-LRRK2 PD patients (including a subset of ~500 patients with monogenic PD patients other than LRRK2) and the establishment of a candidate biomarker in the LRRK2-positive cohort.


Condition or disease Intervention/treatment
Parkinson Disease PARK8 Genetic: Blood Test

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rostock International Parkinson's Disease Study: an International, Multicenter, Epidemiological Observational Study
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson disease individuals Genetic: Blood Test
LRRK2 hotspot mutations and the whole GBA gene will be sequenced. If LRRK2 hotspots and GBA sequencing are both negative and the subject has an early PD onset and/or a PD family history and is willing to participate in further genetic screening, 68 PD associated genes will be sequenced. In case of the negative result and if the participant has an early disease onset and/or a PD family history and is willing to participate in extended genetic screening, Whole Genome Sequencing (WGS) will be performed.

Family member of a participant with LRRK2 parkinsonism Genetic: Blood Test
LRRK2 hotspot mutations and the whole GBA gene will be sequenced. If LRRK2 hotspots and GBA sequencing are both negative and the subject has an early PD onset and/or a PD family history and is willing to participate in further genetic screening, 68 PD associated genes will be sequenced. In case of the negative result and if the participant has an early disease onset and/or a PD family history and is willing to participate in extended genetic screening, Whole Genome Sequencing (WGS) will be performed.

High risk population with an early PD onset Genetic: Blood Test
LRRK2 hotspot mutations and the whole GBA gene will be sequenced. If LRRK2 hotspots and GBA sequencing are both negative and the subject has an early PD onset and/or a PD family history and is willing to participate in further genetic screening, 68 PD associated genes will be sequenced. In case of the negative result and if the participant has an early disease onset and/or a PD family history and is willing to participate in extended genetic screening, Whole Genome Sequencing (WGS) will be performed.




Primary Outcome Measures :
  1. Epidemiological analysis of the prevalence of LRRK2-positive patients in a cohort of PD patients [ Time Frame: 1 day ]
    Number of participants with a mutation/pathogenic variant in their LRRK2 gene within a cohort of 10,000 participants with Parkinson's Disease or are at high risk for Parkinson's Disease, tested using a dry blood sample and next generation sequencing with confirmation by Sanger sequencing


Secondary Outcome Measures :
  1. Epidemiological analysis of the prevalence of patients with PD-related gene alterations (other than LRRK2 gene) in a cohort of PD patients [ Time Frame: 1 day ]
    Number of patients showing with a mutation/pathogenic variant in their PD-related genes (other than LRRK2 gene) within a cohort of 10,000 with Parkinson's Disease or are at high risk for Parkinson's Disease, tested using a dry blood sample and next generation sequencing with confirmation by Sanger sequencing


Other Outcome Measures:
  1. Establishment of candidate LRRK2-positive biomarkers in the LRRK2-positive cohort [ Time Frame: 1 day ]
    The quantitative determination of small molecules (molecular weight 150-700 kD, given as ng/μl) within a dried blood spot sample in LRRK2-mutation positive Parkinson's participants will be validated via liquid chromatography multiple reaction-monitoring mass spectrometry and compared with LRRK2-mutation negative Parkinson's participants as well as LRRK2 mutation carriers (without Parkinson's disease)


Biospecimen Retention:   Samples With DNA

The participants fulfilling the eligibility criteria will be enrolled into the Study and genetically tested for LRRK2 hotspot mutations and the whole GBA gene will be sequenced. If LRRK2 hotspots and GBA sequencing are both negative and the subject has an early PD onset and/or a PD family history and is willing to participate in further genetic screening, 68 PD associated genes will be sequenced. In case of the negative result and if the participant has an early disease onset and/or a PD family history and is willing to participate in extended genetic screening, Whole Genome Sequencing (WGS) will be performed.

LRRK2-positive samples will be validated for the identification of potential biomarkers (based on MS/MS-Spectroscopy) and compared with a merged control sample in order to establish a LRRK2 specific biomarker.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's disease patients and LRRK2 carriers with an early Parkinson disease onset.
Criteria

Inclusion Criteria:

  • Informed consent is obtained from the participant.
  • The participant is clinically diagnosed with Parkinson's disease or the individual is a family member of a participant with LRRK2 parkinsonism or is a member of a high risk population with an early PD onset.
  • The participant is equal to or older than 18 years old.

Exclusion Criteria:

  • Inability to provide informed consent.
  • The participant is not suffering from Parkinson's disease or the individual is not a family member of a participant with LRRK2 parkinsonism or is not a member of a high risk population.
  • The participant is younger than 18 years old.
  • Previously enrolled in the study.
  • Participant in custody.

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): NCT03866603


Contacts
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Contact: Peter Bauer, Prof. Dr +49 30 2130003 49 Peter.Bauer@centogene.com

Locations
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United States, Florida
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34475
Contact: Anette Nieves, Dr.         
Vero Beach Neurology & Research Institute Recruiting
Vero Beach, Florida, United States, 32960
Contact: Stuart Shafer, Dr.         
United States, Massachusetts
Dent Neurologic Institue Recruiting
Amherst, Massachusetts, United States, 01002
Contact: Bennett Myers, Dr.         
United States, New Jersey
Neuroscience Research Institute of NJ Recruiting
Toms River, New Jersey, United States, 08755
Contact: Gerald Ferencz, Dr         
United States, Washington
Booth Gardner Parkinson's Care Center Recruiting
Kirkland, Washington, United States, 98034
Contact: Pinky Agarwal, Assoc.Prof.Dr.         
Albania
Qendra Spitalore University Recruiting
Tirana, Albania
Contact: Paskal Cullufi, Prof. Dr.         
Germany
Charite University Medicine Recruiting
Berlin, Germany
Contact: Andrea Kuhn, Prof. Dr.         
Gertrudis-Kliniken im Parkison-Zentrum Recruiting
Biskirchen, Germany, 35638
Contact: Ilona Csoti, Dr.         
Universitatsklininkum Carl Gustav Carus die Dresdner Recruiting
Dresden, Germany, 01307
Contact: Bjorn Falkenburger, Prof.         
Asklepios Klinik Barmbek Recruiting
Hamburg, Germany, 22291
Contact: Peter P. Urban, Prof.         
Institute of Neurogenetic Recruiting
Luebeck, Germany, 23562
Contact: Christine Klein, Prof.         
Universitatsklinik fur Neurologie Recruiting
Münster, Germany, 48149
Contact: Tobias Warnecke, Dr         
Centogene AG Active, not recruiting
Rostock, Germany, 18055
Sponsors and Collaborators
Centogene AG Rostock
Investigators
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Study Chair: Arndt Rolfs, PhD Centogene AG Rostock

Publications of Results:
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Responsible Party: Centogene AG Rostock
ClinicalTrials.gov Identifier: NCT03866603     History of Changes
Other Study ID Numbers: ROPAD 01-2019
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The plan will be defined at a later stages

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centogene AG Rostock:
Parkinson disease
Biomarker
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases