NCT03866603

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
20,112

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
15 countries

110 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.4 years

First QC Date

March 1, 2019

Last Update Submit

April 7, 2026

Conditions

Keywords

Parkinson´s diseaseBiomarkerLRRK2GBAPD Genetics

Outcome Measures

Primary Outcomes (1)

  • To investigate the prevalence of genetic etiologies of PD

    79 months

Secondary Outcomes (1)

  • To identify LRRK2-positive PD participants from the primary strata, Establishment of a biomarker in the LRRK2-positive cohort

    79 months

Study Arms (1)

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

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants clinically diagnosed with Parkinson's Disease (PD)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (110)

Tucson Neuroscience Research

Tucson, Arizona, 85710, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

University of California (UC) San Diego

La Jolla, California, 92093, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Parkinson's Disease and Movement Disorder Center of Baco Raton

Baco Raton, Florida, 33486, United States

Location

Linfritz Research Institute

Coral Gables, Florida, 33134, United States

Location

Renstar Medical Research

Ocala, Florida, 34475, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Vero Beach Neurology & Research Institute

Vero Beach, Florida, 32960, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Indiana University, Department of Neurology

Indianapolis, Indiana, 46202, United States

Location

Michigan Institute for Neurological Disorders

Farmington Hills, Michigan, 48334, United States

Location

WR-CRCN

Las Vegas, Nevada, 89106, United States

Location

Neuroscience Research Institute of NJ

Toms River, New Jersey, 08755, United States

Location

Dent Neurologic Institue

Amherst, New York, 14226, United States

Location

Stony Brook University School of Medicine

Brookhaven, New York, 11772, United States

Location

South Shore Neurologic Associates

Patchogue, New York, 11772, United States

Location

Duke University, Department of Neurology

Durham, North Carolina, 27710, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Booth Gardner Parkinson's Care Center

Kirkland, Washington, 98034, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Qendra Spitalore University

Tirana, Albania

Location

University Hospital of Antwerp

Antwerp, 2650, Belgium

Location

UZ Leuven, Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Department of Neurology, Centre Hospitalier Universitaire (CHU) de Leige

Liège, 4000, Belgium

Location

AZ Damiaan, Department of Neurology

Ostend, 1008400, Belgium

Location

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Hospital Ophir Loyola

Belém, Pará, PA-66063-240, Brazil

Location

Federal University of Health Science of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-190, Brazil

Location

Universidade Metropolitana De Santos

Santos, São Paulo, CEP 11.045-002, Brazil

Location

Hospital Universitário Walter Cândido/ Universidade Federal do Ceará

Ceará, 60430-372, Brazil

Location

Hospital Angelina Caron

Curitiba, 83430-000, Brazil

Location

Fundação Hospital Adriano Jorge

Manaus, 1778, Brazil

Location

Carolina São Souza

Ribeirão Preto, 14015-130, Brazil

Location

Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, 14040-900, Brazil

Location

Hospital Universitario Pedro Ernesto (HUPE)

Rio de Janeiro, 20550-000, Brazil

Location

Universidade Federal de São Paulo, UNIFESP

São Paulo, 04040-003, Brazil

Location

Clinica de Neurocirurgia E Neurofisiologia Ltda

São Paulo, 1636, Brazil

Location

Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, 69065-001, Brazil

Location

Toronto Western Hospital, University Health Network, University of Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Universitätsklinik für Neurologie

Aachen, 52074, Germany

Location

Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson

Beelitz, 14547, Germany

Location

Kliniken Beelitz

Beelitz-Heilstätten, 14547, Germany

Location

Charite University Medicine

Berlin, 10117, Germany

Location

Gertrudis-Kliniken im Parkison-Zentrum

Biskirchen, 35638, Germany

Location

St. Josef-Hospital

Bochum, 44791, Germany

Location

Universitätsklinikum Carl Gustav Carus die Dresdner

Dresden, 01307, Germany

Location

Asklepios Klinik Barmbek

Hamburg, 22291, Germany

Location

Universitätsklinik Hamburg-Eppendorf

Hamburg-Eppendorf, 20246, Germany

Location

Universitätsklinik für Neurologie

Jena, 7740, Germany

Location

Paracelsus Elena-Klinik

Kassel, 34128, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Neurologie

Kiel, 24105, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, 23538, Germany

Location

Universitätsklinikum Marburg Klinik und Poliklinik für Neurologie Parkinson Netzwerk Allianz Marburg (PANAMA)

Marburg, 35043, Germany

Location

Diakonie-Klinikum Schwäbisch Hall gGmbH

Schwäbisch Hall, 74523, Germany

Location

Asklepios Fachklinikum Stadtroda Klinik für Neurologie, Schmerztherapie und Schlafmedizin

Stadtroda, 07646, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Mediterraneo Hospital

Athens, 16675, Greece

Location

Samson Assuta Ashdod University Hospital

Ashdod, 7747629, Israel

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Soroka Medical Center

Beersheba, 8457108, Israel

Location

Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

RAMBAM Medical Center

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Rabin MC, Beilinson Campus

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center - TASMC

Tel Aviv, 64239, Israel

Location

AOUP Secondo Policlinico Federico II Napoli

Naples, 80131, Italy

Location

Università di Pavia, Dipartimento di Medicina Molecolare

Pavia, 27100, Italy

Location

Asmn - Irccs

Reggio Emilia, 42123, Italy

Location

I.R.C.C.S. San Raffaele Pisana

Roma, 00163, Italy

Location

St. Olav's Hospital

Trondheim, 7006, Norway

Location

Neurology Department, Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar Universitário de São João

Porto, 4200-319, Portugal

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, Corunna, 15706, Spain

Location

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28049, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, 28922, Spain

Location

Instituto Investigacion Biocruces

Barakaldo, 48903, Spain

Location

Hospital General Unversitario Gregorio Marañón

Madrid, 28007, Spain

Location

HM CINAC | Integrated Neuroscience Center

Móstoles, 28938, Spain

Location

Clinica Universidad de Navarra (CUN)

Pamplona, 31008, Spain

Location

Hospital Universitario Donostia

San Sebastián, 20014, Spain

Location

University Hospital Marqués de Valdecilla

Santander, 39008, Spain

Location

Cukurova University Faculty of Medicine

Sarıçam, Adana, 01790, Turkey (Türkiye)

Location

Istanbul Faculty of Medicine

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

Mersin Faculty of Medicine

Mersin, Mersin, 33110, Turkey (Türkiye)

Location

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

Fairfield General Hospital

Bury, BL9 7TD, United Kingdom

Location

University of Dundee

Dundee, DD1 5EH, United Kingdom

Location

University of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

Newcastle University, Clinical Ageing Research Unit

Newcastle upon Tyne, NE4 5PL, United Kingdom

Location

University of Oxford, Nuffield Department of Clinical Neurosciences

Oxford, OX3 9DU, United Kingdom

Location

University of Plymouth

Plymouth, PL6 8BX, United Kingdom

Location

Royal Preston Hospital, Department of Neurology

Preston, PR2 9HT, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

Royal Cornwall Hospitals Nhs Trust

Truro, TR1 3LQ, United Kingdom

Location

Yeovil District Hospital

Yeovil, BA21 4AT, United Kingdom

Location

Related Publications (2)

  • Baumann CR. Epidemiology, diagnosis and differential diagnosis in Parkinson's disease tremor. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S90-2. doi: 10.1016/S1353-8020(11)70029-3.

  • Dayan R, Bick AS, Weill C, Bauer M, Erdman HB, Israel Z, Bergman H, Levin N, Arkadir D. Atrophy-related corticospinal changes in advanced Parkinson's disease are associated with the genetic etiology of the disease. J Parkinsons Dis. 2024 Nov;14(8):1584-1593. doi: 10.3233/JPD-240267. Epub 2024 Nov 4.

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Peter Bauer, MD

    CENTOGENE GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 7, 2019

Study Start

May 30, 2019

Primary Completion

October 10, 2024

Study Completion

October 10, 2024

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The plan will be defined at a later stages

Locations