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

March 21, 2024 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

Recruiting

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 (Estimated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

16 years to 68 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 (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

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)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

September 1, 2023

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

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.

Clinical Trials on Parkinson´s Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe