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Trial record 13 of 19 for:    "Brain Diseases" AND "Multiple System Atrophy" | ( Map: France )

Biomarkers in Parkinsonian Syndromes (BIOPARK)

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ClinicalTrials.gov Identifier: NCT02114242
Recruitment Status : Recruiting
First Posted : April 15, 2014
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date February 6, 2014
First Posted Date April 15, 2014
Last Update Posted Date February 25, 2019
Study Start Date December 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 10, 2014)
Concentration of oligomeric alpha-synuclein in cerebrospinal fluid [ Time Frame: at day 0 (inclusion) and one year after inclusion ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02114242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 10, 2014)
  • Total alpha-synuclein concentration in CSF, oligomeric/total alpha-synuclein ratio in CSF [ Time Frame: At inclusion (Day 0) and one year after inclusion ]
  • Oligomeric and total alpha-synuclein concentration in plasma, oligomeric/total alpha-synuclein ratio in plasma [ Time Frame: At inclusion (Day 0) and one year after inclusion ]
  • Alpha-synuclein levels in relation to disease severity and progression, disease duration and age [ Time Frame: At inclusion (Day 0) and one year after inclusion ]
  • Variation of alpha-synuclein levels between first and second sampling [ Time Frame: At inclusion (Day 0) and one year after inclusion ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers in Parkinsonian Syndromes
Official Title Development of Biomarkers for the Diagnosis and Prognosis of Parkinsonian Syndromes Running Head: Biomarkers in Parkinsonian Syndromes
Brief Summary

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.

Detailed Description

The differential diagnosis between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy can be very difficult in early disease. PD, MSA and PSP are neurodegenerative disorders. PD and MSA belong to the alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. Alpha-synuclein accumulates in intraneuronal Lewy bodies in PD patients and as intracytoplasmic glial inclusions in MSA. In PSP, tau protein accumulates in neurons and glia cells while alpha-synuclein deposits are only found to a small extend.

The development of biological markers for the diagnosis and prognosis of PD, MSA and PSP remains an unmet need. Beyond guiding clinical decision-making, 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 of PD and MSA. The oligomeric alpha-synuclein fraction whose CSF levels are increased in PD seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.

The main objective of the study is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. Secondary objectives are (i) to compare total alpha-synuclein levels and the index total/oligomeric alpha-synuclein between PD, MSA and PSP, (ii) to study the correlation and concordance between CSF and plasma levels of total and oligomeric alpha-synuclein, (iii) to assess potential associations between the biomarker and clinical measures of disease severity and progression and (iv) to assess the variation of the biomarker over time and its correlation to disease severity and progression.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • Cerebrospinal fluid
  • Whole blood
  • Plasma
  • Serum
  • Urine
Sampling Method Probability Sample
Study Population Patients suffering from parkinson disease or multiple system atrophy or progressive supranuclear palsy.
Condition
  • Parkinsonian Syndromes
  • Parkinson's Disease
  • Multiple System Atrophy
  • Progressive Supranuclear Palsy
Intervention
  • Other: CSF, blood and urine sampling
    PSP and MSA patients will receive CSF and blood sampling at two study visits (baseline and after 12 months).
  • Other: clinical measures of disease severity and progression
    Questionnaires (quality of life, motricity scales, cognitive scales, depression scales, scale of sleep quality)
Study Groups/Cohorts
  • Parkinson's disease patients
    Patients suffering from Parkinson desease
    Intervention: Other: clinical measures of disease severity and progression
  • multiple system atrophy patients
    Patients suffering from "probable" multiple system atrophy according to clinical consensus criteria and age > 30
    Interventions:
    • Other: CSF, blood and urine sampling
    • Other: clinical measures of disease severity and progression
  • progressive supranuclear palsy
    Patients suffering from progressive supranuclear palsy and age > 40
    Interventions:
    • Other: CSF, blood and urine sampling
    • Other: clinical measures of disease severity and progression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 10, 2014)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Wassilios MEISSNER, Pr wassilios.meissner@chu-bordeaux.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02114242
Other Study ID Numbers CHUBX 2012/27
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators
Principal Investigator: Wassilios MEISSNER, Pr University Hospital, Bordeaux
Study Chair: Rodolphe THIEBAUT, MD University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date February 2019