Towards the Validation of a New Blood Biomarker for the Early Diagnosis of Parkinson's Disease
NCT ID: NCT05385315
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2022-10-13
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Parkinson's Disease, de novo
patients with de novo PD, without dopaminergic treatment
No interventions assigned to this group
Parkinson's Disease, advanced stage
PD patients with diagnosis \>5years, with dopaminergic treatment and motor fluctuations.
No interventions assigned to this group
Multiple system atrophy
patients with multiple system atrophy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients with advanced Parkinson's disease (\> 5years) with dopaminergic treatment
* Patients with multiple system atrophy
Exclusion Criteria
* Other neurodegenerative diseases
* patients protected by french law (pregnant or lactating women, prisoners, ...)
18 Years
ALL
No
Sponsors
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Grenoble Institut des Neurosciences
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Elena Moro
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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CHU Grenoble Alpes
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Florence FAUVELLE
Role: primary
Andrea KISTNER, PhD
Role: backup
ELENA MORO
Role: backup
References
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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.
Other Identifiers
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2022-A00337-36
Identifier Type: OTHER
Identifier Source: secondary_id
38RC21.0421
Identifier Type: -
Identifier Source: org_study_id