Towards the Validation of a New Blood Biomarker for the Early Diagnosis of Parkinson's Disease

Parkinson Disease Clinical Trial

— BIOPARK  

Official title:

Evaluation de la Performance Clinique d'un Nouveau Biomarqueur Sanguin Des Phases précoces de la Maladie de Parkinson

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385315
• Other study ID #: 38RC21.0421
• Secondary ID: 2022-A00337-36
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Grenoble
• Contact: Florence Fauvelle, PhD
• Phone: (33)456520600
• Email: florence.fauvelle[@]univ-grenoble-alpes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 31, 2025
• Est. primary completion date: October 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with de novo Parkinson's disease, without dopaminergic treatment

• Patients with advanced Parkinson's disease (> 5years) with dopaminergic treatment

• Patients with multiple system atrophy

Exclusion Criteria:

• Patients with deep brain stimulation

• Other neurodegenerative diseases

• patients protected by french law (pregnant or lactating women, prisoners, ...)

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Grenoble Institut des Neurosciences

Country where clinical trial is conducted

France, 

References & Publications (1)

Mallet D, Dufourd T, Decourt M, Carcenac C, Bossu P, Verlin L, Fernagut PO, Benoit-Marand M, Spalletta G, Barbier EL, Carnicella S, Sgambato V, Fauvelle F, Boulet S. A metabolic biomarker predicts Parkinson's disease at the early stages in patients and animal models. J Clin Invest. 2022 Feb 15;132(4):e146400. doi: 10.1172/JCI146400. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	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	2 years
Secondary	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)	2 years
Secondary	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	2 years