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NCT02114242: BIOPARK

Biomarkers in Parkinsonian Syndromes

Status unknown Last updated 31 March 2022
What this trial tests

trial testing CSF, blood and urine sampling in Parkinsonian Syndromes in 100 participants. Status unknown.

Timeline
16 December 2013
Primary endpoint
16 December 2023
16 December 2025

Quick facts

Lead sponsorUniversity Hospital, Bordeaux
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date16 December 2013
Primary completion16 December 2023
Estimated completion16 December 2025
Sites3 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Parkinsonian Syndromes or Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Diagnostic value of cerebrospinal fluid alpha-synuclein seed quantification in synucleinopathies.
    Poggiolini I, Gupta V, Lawton M, Lee S, et al · · 2022 · cited 161× · PMID 34894214 · DOI 10.1093/brain/awab431
  2. "Janus-Faced" α-Synuclein: Role in Parkinson's Disease.
    Ray B, Mahalakshmi AM, Tuladhar S, Bhat A, et al · · 2021 · cited 7× · PMID 34124057 · DOI 10.3389/fcell.2021.673395

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