Biomarkers in Parkinsonian Syndromes

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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


Primary Outcome

Concentration of oligomeric alpha-synuclein in cerebrospinal fluid

Secondary Outcome

 Total alpha-synuclein concentration in CSF, oligomeric/total alpha-synuclein ratio in CSF

Condition

Parkinsonian Syndromes

Intervention

CSF, blood and urine sampling

Study Arms / Comparison Groups

 Parkinson's disease patients
Description:  Patients suffering from Parkinson desease

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

December 16, 2013

Completion Date

December 16, 2023

Primary Completion Date

December 16, 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Wassilios MEISSNER, Pr, , [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02114242

Organization ID

CHUBX 2012/27


Responsible Party

Sponsor

Study Sponsor

University Hospital, Bordeaux


Study Sponsor

Wassilios MEISSNER, Pr, Principal Investigator, University Hospital, Bordeaux


Verification Date

April 2020