Clinical trial NCT05266872: Earlier Diagnosis and Better Treatment Mission Related to the Cohort Programme
Official title: Biomaterial Collection for Neurodegenerative Disease Research (ND Collection)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson's disease
longitudinal cohort
stratification
risk factors
Lead sponsor: Luxembourg Institute of Health
Sponsor class: OTHER_GOV
Collaborators: name: University of Luxembourg
name: Laboratoire National de Santé (LNS)
name: Centre Hospitalier du Luxembourg
First posted: 2022-03-04
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: 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
timeFrame: through study completion, an average of 8 years
measure: 2. Stratification of parkinsonism into subtypes and definition of individual progression trajectories of PD.
timeFrame: through study completion, an average of 8 years
measure: Determine Parkinson's disease biomarker signatures
timeFrame: through study completion, an average of 8 years
measure: Develop a mechanistic understanding of the disease
timeFrame: through study completion, an average of 8 years
Secondary outcomes:
measure: Inform future studies testing new therapies for Parkinson's disease
timeFrame: through study completion, an average of 8 years
measure: Harmonization of data with international Parkinson's disease cohort studies
timeFrame: through study completion, an average of 8 years
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg (CHL), "Parkinson's Research Clinic"
city: Luxembourg
country: Luxembourg
facility: Clinical and Epidemiological Investigation Center (CIEC)
Study officials:
affiliation: Luxembourg Institute of Health
name: Rejko Rejko, Dr
role: PRINCIPAL_INVESTIGATOR
References: