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Recruiting NCT05266872

Earlier Diagnosis and Better Treatment Mission Related to the Cohort Programme

— Observational Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational study with sample and data collection.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Luxembourg
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biomaterial Collection for Neurodegenerative Disease Research (ND Collection)

Overview

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.

Interventions

  • Other Observational study with sample and data collection
    Observational study with sample and data collection

Primary outcome measures

  • 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 [Time frame: through study completion, an average of 8 years]
  • 2. Stratification of parkinsonism into subtypes and definition of individual progression trajectories of PD. [Time frame: through study completion, an average of 8 years]
  • Determine Parkinson's disease biomarker signatures [Time frame: through study completion, an average of 8 years]
  • Develop a mechanistic understanding of the disease [Time frame: through study completion, an average of 8 years]
Secondary outcome measures (2)
  • Inform future studies testing new therapies for Parkinson's disease [Time frame: through study completion, an average of 8 years]
  • Harmonization of data with international Parkinson's disease cohort studies [Time frame: through study completion, an average of 8 years]

Eligibility criteria

Inclusion criteria

  • 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
  • Subjects of at least 18 years of age at the time of inclusion

Exclusion criteria

  • Refusal to sign the informed consent
  • Limited capacity of consent on the part of the donor, if there is no legally determined guardian/authorised representative, or the latter is not present or does not agree with the inclusion
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Luxembourg · 2 centers
  • Centre Hospitalier de Luxembourg (CHL), "Parkinson's Research Clinic" — Luxembourg
  • Clinical and Epidemiological Investigation Center (CIEC) — Luxembourg

Publications

  • 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 dise PMID 38174101

Identifiers

NCT: NCT05266872 · CNER 140174_ND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗