Earlier Diagnosis and Better Treatment Mission Related to the Cohort Programme

NCT05266872 | Recruiting DMC

• 1 other identifier: CNER 140174_ND
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 2

Brief Summary

The Luxembourg Parkinson's Study is an ongoing longitudinal nationwide monocentric observational study. It collects extensive clinical, molecular, genetic, and digital device-based longitudinal data, as well as foreseen post-mortem diagnostic validation (Hipp et al., 2018). The cohort consists of more than 1,600 participants from Luxembourg and the Greater Region, comprising patients with typical PD or atypical parkinsonism - irrespective of disease stage, age, cognitive status, comorbidities, or linguistic background - followed-up annually and age- and sex-matched healthy control subjects followed-up every 4 years. To provide a large, longitudinally followed, and deeply phenotyped set of patients and controls for clinical and fundamental research on PD, the investigators have implemented an open-source digital platform that has been partly harmonized with other international PD cohort studies. This effort is flanked by comprehensive biosampling efforts assuring high quality and sustained availability of body liquids and tissue biopsies (including blood, urine, stool, saliva, hair, skin biopsy and cerebrospinal fluid). All data and samples are stored, curated, and integrated into state-of-the-art data and biobank facilities.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; longitudinal cohort; stratification; risk factors

Outcome Measures

Primary Outcomes (4)

• 1. Establish an open collection of a large set of diverse longitudinal bio-samples and data for research in 800 PD patients and 800 controls

  1.1. Samples will be aliquoted and stored according to the highest standards at the IBBL for future research.

  through study completion, an average of 8 years

• 2. Stratification of parkinsonism into subtypes and definition of individual progression trajectories of PD.

  2.1. Identify PD patients' subgroups with a similar pattern of disease progression. datasets.

  through study completion, an average of 8 years

• Determine Parkinson's disease biomarker signatures

  3.1. Identify new and early diagnostic biomarkers

  through study completion, an average of 8 years

• Develop a mechanistic understanding of the disease

  4.1. Understand the mechanisms of PD pathogenesis.

  through study completion, an average of 8 years

Secondary Outcomes (2)

• Inform future studies testing new therapies for Parkinson's disease

  through study completion, an average of 8 years

• Harmonization of data with international Parkinson's disease cohort studies

  through study completion, an average of 8 years

Study Arms (2)

PD patients

Subjects with neurodegenerative disease or having degenerative parkinsonism (typical PD or atypical parkinsonism)

Other: Observational study with sample and data collection

Healthy controls

Gender- and age-matched healthy controls

Other: Observational study with sample and data collection

Interventions

Observational study with sample and data collection OTHER

Observational study with sample and data collection

Healthy controls; PD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a neurodegenerative disease or having degenerative parkinsonism (typical PD or atypical parkinsonism) and gender- and age-matched healthy controls.

You may qualify if:

• Subjects with neurodegenerative disease or having Parkinson's disease (typical PD or atypical parkinsonism)
• Subjects of all genders with a full capacity of consent
• Subjects with a limited consent capacity if the legal guardian/authorised representative is in agreement

You may not qualify if:

• Refusal to sign the informed consent
• Active cancer
• Pregnant women
• Underage subjects of less than 18 years of age
• Refusal to comply with mandatory sample collection
• For invasive procedures, i.e., lumbar puncture and skin biopsy: relevant blood clotting impairment, e.g., anamnestic evidence of frequent or prolonged bleedings.

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• University of Luxembourg: collaborator
• Laboratoire National de Santé (LNS): collaborator
• Centre Hospitalier du Luxembourg: collaborator

Study Sites (2)

Centre Hospitalier de Luxembourg (CHL), "Parkinson's Research Clinic"

Luxembourg, 1210, Luxembourg

RECRUITING

Clinical and Epidemiological Investigation Center (CIEC)

Luxembourg, 1445, Luxembourg

RECRUITING

Related Publications (1)

• Pavelka L, Rawal R, Ghosh S, Pauly C, Pauly L, Hanff AM, Kolber PL, Jonsdottir SR, Mcintyre D, Azaiz K, Thiry E, Vilasboas L, Soboleva E, Giraitis M, Tsurkalenko O, Sapienza S, Diederich N, Klucken J, Glaab E, Aguayo GA, Jubal ER, Perquin M, Vaillant M, May P, Gantenbein M, Satagopam VP, Kruger R; NCER-PD Consortium. Luxembourg Parkinson's study -comprehensive baseline analysis of Parkinson's disease and atypical parkinsonism. Front Neurol. 2023 Dec 19;14:1330321. doi: 10.3389/fneur.2023.1330321. eCollection 2023.

  PMID: 38174101 DERIVED

Related Links

• Website accessible by participants and researcher giving information on the study an related activities
• Publication on the initial cohort

Biospecimen

Retention: SAMPLES WITH DNA

At inclusion and Follow-up: Blood; Urine; Saliva Optional: Hair; Nasal washes; Nasal brushes; skin biopsy; Stool sample; Cerebrospinal Fluid Sample - lumbar puncture; Colorectal tissue sample (if colonoscopy required in SoC)

MeSH Terms

Conditions

Parkinson Disease

Interventions

Observation; Data Collection

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rejko Rejko, Dr

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rejko KRÜGER, Dr

CONTACT

+352 44 11 4848; rejko.krueger@uni.lu

Parkinson clinic

CONTACT

+352 44 11 4848; parkinson@chl.lu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: March 4, 2022
• Study Start: December 19, 2014
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

LU (2)