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

April 7, 2026 updated by: CENTOGENE GmbH Rostock

Rostock International Parkinson's Disease Study: an International, Multicenter, Epidemiological Observational Study

Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Clinical signs and symptoms of PD include the following: asymmetric tremor at rest, bradykinesia, muscle rigidity, postural instability, gait abnormalities including festination and freezing. Onset is typically after the age of 50 years and the disease is commonly slowly progressive. The most common initial finding of PD is a resting tremor in the upper extremity. Over time, participants experience progressive bradykinesia, rigidity, and gait difficulty, while the axial posture becomes progressively flexed. Non-motor symptoms are common in all stages of Parkinson disease and they include constipation, seborrhea, hyposmia or anosmia, sympathetic denervation of the heart, depression and/or apathy, sleep disturbances, cognitive decline and dementia. They may appear prior to the movement disorder and can be used as preclinical markers of PD.

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 most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD. First identified in 2004, LRRK2 mutations are currently still the most commonly known cause of PD and account for up to ~40% of all Parkinson's disease cases in select populations. The majority of reported LRRK2-positive PD patients are Caucasian (63%), whereas all other ethnicities comprise ~10% or fewer patients of described mutation carriers despite clusters in the Ashkenazi Jewish and Arab Berber populations. With respect to country of origin, the majority of patients were re-ported to reside in Italy or Spain (14% each), Great Britain (10%) or Norway (9%). Definitely pathogenic variants identified in LRRK2 include p.G2019S, p.R1441C/G/H, p.N1437H, p.Y1699C, and, p.I2020T. Of these, the p.R1441G mutation is particularly frequent, as it represents a founder mutation in the Basque population where it is responsible for 46% of all familial PD. Very rarely, this mutation has also been observed in other populations where it arose on a different haplotype. LRRK2 p.Gly2019Ser mutation accounts for about 0.5% simplex cases and >5% familial cases in various ethnic groups worldwide. Furthermore, genome-wide association studies have identified common polymorphisms in LRRK2 that associate with idiopathic PD, implicating LRRK2 function in susceptibility to late-onset PD in individuals without pathogenic mutations.

LRRK2 mutations cause PD with age-related penetrance and clinical features identical to late-onset sporadic PD. Biochemical studies support an increase in LRRK2 kinase activity and a decrease in GTPase activity for kinase domain and Roc-COR mutations, respectively. Strong evidence exists that LRRK2 toxicity is kinase dependent, leading to extensive efforts to identify selective and brain-permeable LRRK2 kinase inhibitors for clinical development. LRRK2 kinase inhibition is currently one of the most prevailing disease-modifying therapeutic strategies for PD. Thus, LRRK2 kinase inhibitors are in development as potential Parkinson's disease therapeutics.

Furthermore, there is now evidence showing that LRRK2 expression and phosphorylation levels have a potential as markers of Parkinson's disease. Recently, the presence of Lrrk2 was confirmed in exosomes from human biofluids, including urine and cerebrospinal fluid. Moreover, elevated LRRK2 autophosphorylation was identified in brain-derived and peripheral exosomes in LRRK2-mutation carriers. In summary, it has been shown that markers of LRRK2 activity and function may be detected in human blood and that they are relevant for pathogenesis if PD.

Thus, the biochemical analyses of human blood from LRRK2 positive participants and LRRK2 negative participants create a strong base for the development of PD-related biomarkers. This biomarker may in turn be even more accessible than genetic testing and it may serve for diagnosis, prognosis, and prediction of PD.

Study Type

Observational

Enrollment (Actual)

20112

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

  • Albania
      • Tirana, Albania
        • Qendra Spitalore University
  • Belgium
      • Antwerp, Belgium, 2650
        • University Hospital of Antwerp
      • Leuven, Belgium, 3000
        • UZ Leuven, Campus Gasthuisberg
      • Liège, Belgium, 4000
        • Department of Neurology, Centre Hospitalier Universitaire (CHU) de Leige
      • Ostend, Belgium, 1008400
        • AZ Damiaan, Department of Neurology
  • Brazil
      • Ceará, Brazil, 60430-372
        • Hospital Universitário Walter Cândido/ Universidade Federal do Ceará
      • Curitiba, Brazil, 83430-000
        • Hospital Angelina Caron
      • Manaus, Brazil, 1778
        • Fundação Hospital Adriano Jorge
      • Ribeirão Preto, Brazil, 14015-130
        • Carolina São Souza
      • Ribeirão Preto, Brazil, 14040-900
        • Faculdade de Medicina de Ribeirão Preto - USP
      • Rio de Janeiro, Brazil, 20550-000
        • Hospital Universitario Pedro Ernesto (HUPE)
      • São Paulo, Brazil, 04040-003
        • Universidade Federal de São Paulo, UNIFESP
      • São Paulo, Brazil, 1636
        • Clinica de Neurocirurgia E Neurofisiologia Ltda
      • São Paulo, Brazil, 69065-001
        • Instituto Israelita de Ensino e Pesquisa Albert Einstein
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Hospital das Clinicas da Universidade Federal de Minas Gerais
    • Pará
      • Belém, Pará, Brazil, PA-66063-240
        • Hospital Ophir Loyola
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-190
        • Federal University of Health Science of Porto Alegre
    • São Paulo
      • Santos, São Paulo, Brazil, CEP 11.045-002
        • Universidade Metropolitana de Santos
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital, University Health Network, University of Toronto
  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinik für Neurologie
      • Beelitz, Germany, 14547
        • Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson
      • Beelitz-Heilstätten, Germany, 14547
        • Kliniken Beelitz
      • Berlin, Germany, 10117
        • Charité University Medicine
      • Biskirchen, Germany, 35638
        • Gertrudis-Kliniken im Parkison-Zentrum
      • Bochum, Germany, 44791
        • St. Josef-Hospital
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus die Dresdner
      • Hamburg, Germany, 22291
        • Asklepios Klinik Barmbek
      • Hamburg-Eppendorf, Germany, 20246
        • Universitätsklinik Hamburg-Eppendorf
      • Jena, Germany, 7740
        • Universitätsklinik für Neurologie
      • Kassel, Germany, 34128
        • Paracelsus Elena-Klinik
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Klinik für Neurologie
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • Marburg, Germany, 35043
        • Universitätsklinikum Marburg Klinik und Poliklinik für Neurologie Parkinson Netzwerk Allianz Marburg (PANAMA)
      • Schwäbisch Hall, Germany, 74523
        • Diakonie-Klinikum Schwäbisch Hall gGmbH
      • Stadtroda, Germany, 07646
        • Asklepios Fachklinikum Stadtroda Klinik für Neurologie, Schmerztherapie und Schlafmedizin
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Greece
      • Athens, Greece, 16675
        • Mediterraneo Hospital
  • Israel
      • Ashdod, Israel, 7747629
        • Samson Assuta Ashdod University Hospital
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center
      • Beersheba, Israel, 8457108
        • Soroka Medical Center
      • Be’er Ya‘aqov, Israel
        • Shamir Medical Center
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin MC, Beilinson Campus
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center - TASMC
  • Italy
      • Naples, Italy, 80131
        • AOUP Secondo Policlinico Federico II Napoli
      • Pavia, Italy, 27100
        • Università di Pavia, Dipartimento di Medicina Molecolare
      • Reggio Emilia, Italy, 42123
        • Asmn - Irccs
      • Roma, Italy, 00163
        • I.R.C.C.S. San Raffaele Pisana
  • Norway
      • Trondheim, Norway, 7006
        • St. Olav's Hospital
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Neurology Department, Hospital de Santa Maria
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao
  • Spain
      • Alcorcón, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Barakaldo, Spain, 48903
        • Instituto Investigacion Biocruces
      • Madrid, Spain, 28007
        • Hospital General Unversitario Gregorio Marañón
      • Móstoles, Spain, 28938
        • HM CINAC | Integrated Neuroscience Center
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra (Cun)
      • San Sebastián, Spain, 20014
        • Hospital Universitario Donostia
      • Santander, Spain, 39008
        • University Hospital Marqués de Valdecilla
    • Barcelona
      • Barcelona, Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • Corunna
      • Santiago de Compostela, Corunna, Spain, 15706
        • Hospital Clinico Universitario Santiago de Compostela
    • Madrid
      • Madrid, Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Madrid, Madrid, Spain, 28049
        • Hospital Clinico San Carlos
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34010
        • Koc University Hospital
    • Adana
      • Sarıçam, Adana, Turkey (Türkiye), 01790
        • Cukurova University Faculty of Medicine
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34093
        • Istanbul Faculty of Medicine
    • Mersin
      • Mersin, Mersin, Turkey (Türkiye), 33110
        • Mersin Faculty of Medicine
  • United Kingdom
      • Bury, United Kingdom, BL9 7TD
        • Fairfield General Hospital
      • Dundee, United Kingdom, DD1 5EH
        • University of Dundee
      • Edinburgh, United Kingdom, EH16 4SB
        • University of Edinburgh
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust
      • Newcastle upon Tyne, United Kingdom, NE4 5PL
        • Newcastle University, Clinical Ageing Research Unit
      • Oxford, United Kingdom, OX3 9DU
        • University of Oxford, Nuffield Department of Clinical Neurosciences
      • Plymouth, United Kingdom, PL6 8BX
        • University of Plymouth
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital, Department of Neurology
      • Salford, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospitals NHS Trust
      • Yeovil, United Kingdom, BA21 4AT
        • Yeovil District Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Tucson Neuroscience Research
    • California
      • Encino, California, United States, 91316
        • Pharmacology Research Institute
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • La Jolla, California, United States, 92093
        • University of California (UC) San Diego
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
    • Florida
      • Baco Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorder Center of Baco Raton
      • Coral Gables, Florida, United States, 33134
        • Linfritz Research Institute
      • Ocala, Florida, United States, 34475
        • Renstar Medical Research
      • Tampa, Florida, United States, 33613
        • University of South Florida
      • Vero Beach, Florida, United States, 32960
        • Vero Beach Neurology & Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University, Department of Neurology
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Institute for Neurological Disorders
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • WR-CRCN
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Neuroscience Research Institute of NJ
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institue
      • Brookhaven, New York, United States, 11772
        • Stony Brook University School of Medicine
      • Patchogue, New York, United States, 11772
        • South Shore Neurologic Associates
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University, Department of Neurology
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research, Inc.
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch, LLC
    • Washington
      • Kirkland, Washington, United States, 98034
        • Booth Gardner Parkinson's Care Center
      • Spokane, Washington, United States, 99202
        • Inland Northwest Research

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

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants clinically diagnosed with Parkinson's Disease (PD)

Description

  • Informed consent is obtained from the participant
  • The participant has been clinically diagnosed with Parkinson's disease within the last 5 years (≤ 5 years)
  • The participant is between 30 and 80 years old

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Parkinson´s disease individuals
  • The participant has been clinically diagnosed with Parkinson's disease within the last 5 years (≤ 5 years)
  • The participant is between 30 and 80 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the prevalence of genetic etiologies of PD
Time Frame: 79 months
79 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To identify LRRK2-positive PD participants from the primary strata, Establishment of a biomarker in the LRRK2-positive cohort
Time Frame: 79 months
79 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CENTOGENE GmbH Rostock

Investigators

  • Principal Investigator: Peter Bauer, MD, CENTOGENE GmbH

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.

General Publications

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)

May 30, 2019

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

October 10, 2024

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROPAD 01-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The plan will be defined at a later stages

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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