Earlier Diagnosis and Better Treatment Mission Related to the Cohort Programme

Parkinson Disease Clinical Trial

— LuxPARK  

Official title:

Biomaterial Collection for Neurodegenerative Disease Research (ND Collection)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266872
• Other study ID #: CNER 140174_ND
• Status: Recruiting
• Start date: December 19, 2014
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Luxembourg Institute of Health
• Contact: Rejko KRÜGER, Dr
• Phone: +352 44 11 4848
• Email: rejko.krueger[@]uni.lu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Luxembourg	Centre Hospitalier de Luxembourg (CHL), "Parkinson's Research Clinic"	Luxembourg
Luxembourg	Clinical and Epidemiological Investigation Center (CIEC)	Luxembourg

Sponsors (4)

Lead Sponsor	Collaborator
Luxembourg Institute of Health	Centre Hospitalier du Luxembourg, Laboratoire National de Santé (LNS), Luxembourg Centre for Systems Biomedicine (LCSB), University of Luxembourg - Co-sponsor

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Determine Parkinson's disease biomarker signatures	3.1. Identify new and early diagnostic biomarkers	through study completion, an average of 8 years
Primary	Develop a mechanistic understanding of the disease	4.1. Understand the mechanisms of PD pathogenesis.	through study completion, an average of 8 years
Secondary	Inform future studies testing new therapies for Parkinson's disease	1.1. Enable future studies, such as clinical trials, by sharing the findings of mechanisms of PD pathogenesis and identifying new therapeutic targets.	through study completion, an average of 8 years
Secondary	Harmonization of data with international Parkinson's disease cohort studies	2.1. Data collected in this study will be harmonized with the international PD research community through an open-source digital platform.	through study completion, an average of 8 years

External Links

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