Biomarkers in Parkinsonian Syndromes (BIOPARK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT02114242
First received: February 6, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Parkinsonian Syndromes
Parkinson's Disease
Multiple System Atrophy
Progressive Supranuclear Palsy
Other: CSF, blood and urine sampling
Other: clinical measures of disease severity and progression

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Development of Biomarkers for the Diagnosis and Prognosis of Parkinsonian Syndromes Running Head: Biomarkers in Parkinsonian Syndromes

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Concentration of oligomeric alpha-synuclein in cerebrospinal fluid [ Time Frame: at day 0 (inclusion) and one year after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total alpha-synuclein concentration in CSF, oligomeric/total alpha-synuclein ratio in CSF [ Time Frame: At inclusion (Day 0) and one year after inclusion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Variation of alpha-synuclein levels between first and second sampling [ Time Frame: At inclusion (Day 0) and one year after inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
  • Cerebrospinal fluid
  • Whole blood
  • Plasma
  • Serum
  • Urine

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parkinson's disease patients
Patients suffering from Parkinson desease
Other: clinical measures of disease severity and progression
Questionnaires (quality of life, motricity scales, cognitive scales, depression scales, scale of sleep quality)
multiple system atrophy patients
Patients suffering from "probable" multiple system atrophy according to clinical consensus criteria and age > 30
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)
progressive supranuclear palsy
Patients suffering from progressive supranuclear palsy and age > 40
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suffering from parkinson disease or multiple system atrophy or progressive supranuclear palsy.

Criteria
  • 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 "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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02114242

Contacts
Contact: Wassilios MEISSNER, Pr wassilios.meissner@chu-bordeaux.fr

Locations
France
CHU de Limoges Not yet recruiting
Limoges, France, 87000
Contact: Frédéric Torny, MD         
Principal Investigator: Frédéric Torny, MD         
Sub-Investigator: Philippe Couratier, Pr         
CHU de Bordeaux Recruiting
Pessac, France, 33640
Contact: Wassilios MEISSNER, Pr         
Principal Investigator: Wassilios MEISSNER, Pr         
Sub-Investigator: François TISON, Pr         
Sub-Investigator: Alexandra Foubert-Samier, MD         
Sub-Investigator: Olivier Flabeau, Md         
CHU de Toulouse Not yet recruiting
Toulouse, France, 31000
Contact: Olivier RASCOL, Pr         
Principal Investigator: Olivier RASCOL, PR         
Sub-Investigator: Anne Pavy-Le Traon, MD         
Sub-Investigator: Christine Brefel-Courbon, Dr         
Sub-Investigator: Fabienne Ory-Magne, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Wassilios MEISSNER, Pr Bordeaux University Hospital
Study Chair: Rodolphe THIEBAUT, MD Bordeaux university hospital
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02114242     History of Changes
Other Study ID Numbers: CHUBX 2012/27
Study First Received: February 6, 2014
Last Updated: April 10, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Bordeaux:
Parkinson's disease
multiple system atrophy
progressive supranuclear palsy
alpha-synuclein

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Central Nervous System Diseases
Nervous System Diseases
Autonomic Nervous System Diseases
Parkinson Disease
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Primary Dysautonomias
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014