CHU Grenoble Alpes
Grenoble, 38043, France
Location status: Recruiting
Location contact
Andrea KISTNER, PhD
CONTACT
ELENA MORO
CONTACT
Florence FAUVELLE
CONTACT
NCT Number: NCT05385315
The investigators have recently discovered a metabolic biomarker which predicts Parkinson's disease (PD) at the early stages in patients and in animal models. The aim of BIOPARK is to investigate how the biomarker evolves in advanced PD stage, when diagnosis confirmation is higher, an in de novo PD patients who come from a different geographical area than those of the publication (since it is known that the metabolome is largely influenced by lifestyle). They will also evaluate if the biomarker is able to distinguish patients with a parkinsonian syndrome often confused with parkinson's disease, i.e. Multiple System Atrophy (MSA).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Grenoble, 38043, France
Location status: Recruiting
Andrea KISTNER, PhD
CONTACT
ELENA MORO
CONTACT
Florence FAUVELLE
CONTACT
Parkinson's disease (PD) affects more than 7 million people worldwide and represents a growing health and socio-economic burden. It is an incurable neurodegenerative disease, and the search for biomarkers that allow reliable early diagnosis and provide new therapeutic targets is essential to find cures for PD.
In a recently published preclinical and clinical study, the investigators have identified in 2 rat models of PD and a primate model and in 2 human cohorts from biobanks significant deregulations of 6 serum metabolites: acetoacetate, betaine, beta-hydroxybutyrate, creatine, pyruvate and valine. From these 6 metabolites, they built a composite biomarker, which allowed to classify de novo parkinsonian patients against controls (healthy subjects) with an accuracy (defined as the ratio (correctly classified/total) of 82.6%. This study demonstrated for the first time that a common metabolic dysregulation occurs early in either animal models or in PD patients, thus providing an unbiased diagnostic tool as well as major hypothesis for the understanding of the pathophysiology of the disease and the development of innovative therapeutic approaches.
The goal of BIOPARK is to improve the clinical diagnosis of early PD using the blood biomarker.
To this end, the investigators will study whether the biomarker is able to differentiate between patients with PD >5 years and already treated with dopaminergic drugs (thus with a very high diagnostic confirmation) and patients suffering from other neurodegenerative diseases often confused with it, mainly Multiple Systeme Atrophy (MSA). Furthermore, the investigators hope to confirm the preliminary results on a new cohort of de novo patients.
For that aim, they will use the already optimized method for biomarker discovery, i.e. Nuclear Magnetic Resonance (NMR)-based metabolomics on patient serum.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
The main objective of the project is to evaluate whether classification with the biomarker is consistent with the diagnosis in a cohort of parkinsonian patients with high diagnostic confirmation, i.e. patients treated with L-Dopa for over 5 years
Time frame: 2 years
The first secondary objective is to assess whether the biomarker predicts disease in a new cohort of de novo parkinsonian patient
Time frame: 2 years
The second secondary objective is to assess the specificity of the blood biomarker for the differential diagnosis of PD (early and late stage) by measuring it in a patient population with probable AMS (which is a pathology confounding for PD)
Time frame: 2 years
The third secondary objective is to assess, for all patients, whether the classification is consistent with the MDS-UPDRS motor score assessed at inclusion
Contact information is provided by the study sponsor or research team.
Andrea Kistner, PhD
CONTACT
Florence Fauvelle, PhD
CONTACT
University Hospital, Grenoble
Other
Evaluation De La Performance Clinique D'un Nouveau Biomarqueur Sanguin Des Phases Précoces De La Maladie De Parkinson
Acronym: BIOPARK
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