An observational study in Parkinson Disease, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University Hospital, Grenoble · Observational
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).
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 70 is below the median of 97 across 1,081 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of patients coming for consultation or admission to day clinic of the neurologic department of the university hospital Grenoble.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
patients with de novo PD, without dopaminergic treatment
PD patients with diagnosis \>5years, with dopaminergic treatment and motor fluctuations.
patients with multiple system atrophy
validation of the biomarker in advanced stage PD
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
Validation of the biomarker in a new cohort of PD patients
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
Specificity of the biomarker for PD
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
Correlation with MDS-UPDRS
The third secondary objective is to assess, for all patients, whether the classification is consistent with the MDS-UPDRS motor score assessed at inclusion
Time frame: 2 years
Started Oct 2022 (actual). Primary completion is estimated for Oct 2025, 36 months after the start.
Of 381 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's planned 36 months is below that.
Counting every sponsor, half of 440 studies reached it within 48 months; a quarter within 21 and three quarters within 112.
How these figures are worked out, and which studies are left out of them.
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