Biomaterial Collection for Neurodegenerative Disease Research (ND Collection)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Luxembourg Institute of Health
- Enrollment
- 1800
- Locations
- 2
- Primary Endpoint
- 2. Stratification of parkinsonism into subtypes and definition of individual progression trajectories of PD.
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
2. Stratification of parkinsonism into subtypes and definition of individual progression trajectories of PD.
Time Frame: through study completion, an average of 8 years
2.1. Identify PD patients' subgroups with a similar pattern of disease progression. datasets.
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
1.1. Samples will be aliquoted and stored according to the highest standards at the IBBL for future research.
Determine Parkinson's disease biomarker signatures
Time Frame: through study completion, an average of 8 years
3.1. Identify new and early diagnostic biomarkers
Develop a mechanistic understanding of the disease
Time Frame: through study completion, an average of 8 years
4.1. Understand the mechanisms of PD pathogenesis.
Secondary Outcomes
- 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)