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

NCT05385315 | Recruiting

• 2 other identifiers: 38RC21.04212022-A00337-36
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Validation of the biomarker in a new cohort of PD patients

  2 years

• Specificity of the biomarker for PD

  2 years

• Correlation with MDS-UPDRS

  2 years

Study Arms (3)

Parkinson's Disease, de novo

patients with de novo PD, without dopaminergic treatment

Parkinson's Disease, advanced stage

PD patients with diagnosis \>5years, with dopaminergic treatment and motor fluctuations.

Multiple system atrophy

patients with multiple system atrophy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients coming for consultation or admission to day clinic of the neurologic department of the university hospital Grenoble.

You may qualify if:

• 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

You may not qualify if:

• Patients with deep brain stimulation
• Other neurodegenerative diseases
• patients protected by french law (pregnant or lactating women, prisoners, ...)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Grenoble Institut des Neurosciences: collaborator

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Related 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.

  PMID: 34914634 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Elena Moro

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Fauvelle, PhD

CONTACT

(33)456520600; florence.fauvelle@univ-grenoble-alpes.fr

Andrea Kistner, PhD

CONTACT

Akistner@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 23, 2022
• Study Start: October 13, 2022
• Primary Completion: October 16, 2025
• Study Completion: December 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

FR (1)