Informations générales (source: ClinicalTrials.gov)
Development of Biomarkers for the Diagnosis and Prognosis of Parkinsonian Syndromes Running Head: Biomarkers in Parkinsonian Syndromes (BIOPARK)
Observational
University Hospital, Bordeaux (Voir sur ClinicalTrials)
décembre 2013
décembre 2025
29 juin 2024
Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy
(PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are
characterized by the abnormal accumulation of alpha-synuclein, while tau protein
accumulates in PSP. The development of biological markers for the diagnosis and prognosis
in PD, MSA and PSP remains an unmet need. Such biological markers are crucial for future
disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for
biomarker development since it constitutes the pathological hallmark feature in PD and
MSA. The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein
aggregation in alpha-synucleinopathies.
The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA
and PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood
sampling at two study visits (baseline and after 12 months). Major secondary objectives
are (i) to assess potential associations between the biomarker and clinical measures of
disease severity and progression in MSA and PSP, and (ii) to assess the variation of the
biomarker and its correlation to disease severity and progression in PD, MSA and PSP.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Bordeaux - 33640 - Pessac - France | Wassilios MEISSNER, Pr | Contact (sur clinicalTrials) | |||
| CHU de Limoges - 87000 - Limoges - France | Frédéric Torny, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Toulouse - 31000 - Toulouse - France | Olivier RASCOL, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
Patients receiving anticoagulants, showing abnormal coagulation on blood testing or
thrombocytopenia are excluded from this study.
Patients showing more than 500 erythrocytes per mm3 of LCR are excluded from this study.
- PD patients
- inclusion criteria:
- Patients suffering from PD according to clinical criteria (Hughes et al,
1992)
- Written informed consent
- Patient covered by the national health system
- exclusion criteria:
- Patient under tutelage
- patient covered by the national health system
- MSA patients
- inclusion criteria:
- Patients suffering from "possible" or "probable" MSA according to clinical
consensus criteria (Gilman et al, 2008), age > 30
- Written informed consent
- Patient covered by the national health system
- exclusion criteria:
- UMSARS IV score >4 points
- Patient under tutelage
- PSP patients
- inclusion criteria:
- Patients suffering from PSP according to NNIPPS trial criteria (Bensimon
et al., 2009), age > 40
- Written informed consent
- Patient covered by the national health system
- exclusion criteria:
- PSPRS item 26 score >3 points
- Patient under tutelage
thrombocytopenia are excluded from this study.
Patients showing more than 500 erythrocytes per mm3 of LCR are excluded from this study.
- PD patients
- inclusion criteria:
- Patients suffering from PD according to clinical criteria (Hughes et al,
1992)
- Written informed consent
- Patient covered by the national health system
- exclusion criteria:
- Patient under tutelage
- patient covered by the national health system
- MSA patients
- inclusion criteria:
- Patients suffering from "possible" or "probable" MSA according to clinical
consensus criteria (Gilman et al, 2008), age > 30
- Written informed consent
- Patient covered by the national health system
- exclusion criteria:
- UMSARS IV score >4 points
- Patient under tutelage
- PSP patients
- inclusion criteria:
- Patients suffering from PSP according to NNIPPS trial criteria (Bensimon
et al., 2009), age > 40
- Written informed consent
- Patient covered by the national health system
- exclusion criteria:
- PSPRS item 26 score >3 points
- Patient under tutelage