Oligomeric Alpha-synuclein in Multiple System Atrophy (BIOAMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01485549
First received: November 29, 2011
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

The main objectives are to determine on one hand whether oligomeric alpha-synuclein levels are increased in MSA patients compared to controls and on other hand whether there is a good agreement between cerebrospinal fluid (CSF) and plasma levels.


Condition
Multiple System Atrophy (MSA)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy

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 (CSF). [ Time Frame: CSF will be collected at inclusion (Day 0) and frozen. Analyses will be performed after last patient last visit (estimated date Jan-2014) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF [ Time Frame: CSF will be collected at inclusion (Day 0) and frozen. Analyses will be performed after last patient last visit (estimated date Jan-2014) ] [ Designated as safety issue: No ]
  • Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma [ Time Frame: CSF will be collected at inclusion (Day 0) and frozen. Analyses will be performed after last patient last visit (estimated date Jan-2014) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
  • cerebrospinal fluid (CSF)
  • whole blood
  • plasma
  • blood serum
  • urine

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
MSA Patients
Patients suffering from Multiple system atrophy (MSA)
Controls
Patients requiring spinal tap without being affected by a neurodegenerative disorder.

Detailed Description:

Multiple system atrophy (MSA) is a rare neurodegenerative disorder which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. No effective treatment is available. Together with PD and Lewy body dementia, MSA belongs to a group of neurodegenerative disorders, the alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. The development of biological markers for the diagnosis and prognosis in MSA 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 MSA. The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.

The study will compare alpha-synuclein levels in CSF and plasma between patients suffering from AMS and controls who are patients requiring spinal tap without being affected by a neurodegenerative disorder. The MSA patients and controls will receive CSF and blood sampling at one study visit.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cases will be selected from cohort of 90 MSA patients referenced in Bordeaux University Hospital.

Controls will be selected from patients requiring spinal tap without being affected by a neurodegenerative disorder and paired in age and gender with cases.

Criteria

Inclusion Criteria:

  • MSA patients :

    • Patients suffering from "probable" MSA according to clinical consensus criteria (Gilman et al, 2008)
    • Age ≥ 30
    • Written informed consent
    • Patient covered by the French health insurance system
  • Controls :

    • Patients not suffering from a neurodegenerative disorder and requiring a spinal tap
    • Age ≥ 30
    • Written informed consent
    • Patient covered by the French health insurance system

Exclusion Criteria:

  • MSA patients :

    • UMSARS IV score > 4 points
    • Patient with coagulopathy, defined by an abnormal activated partial thromboplastin time or INR
    • Patient with thrombocytopenia
    • Patient under tutelage
    • Patient unable to give consent
  • Controls :

    • Patient with coagulopathy, defined by an abnormal activated partial thromboplastin time or INR
    • Patient with thrombocytopenia
    • Patient under tutelage
    • Patient unable to give consent
  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: NCT01485549

Contacts
Contact: Wassilios MEISSNER, MD, PhD (0)557656420 ext +33 wassilios.meissner@chu-borfdeaux.fr
Contact: Olivier Flabeau, CCA olivier.flabeau@chu-bordeaux.fr

Locations
France
Bordeaux University Hospital Recruiting
Pessac, France, 33604
Contact: Wassilios MEISSNER, MD, PhD    (0)557656420 ext +33    wassilios.meissner@chu-bordeaux.fr   
Principal Investigator: Wassilios MEISSNER, MD, PhD         
Sub-Investigator: François TISON, MD, PhD         
Sub-Investigator: Anne-Cécile WIELANEK, MD         
Sub-Investigator: Olivier FLABEAU, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Wassilios MEISSNER, MD, PhD University Hospital, Bordeaux
Study Chair: Rodolphe THIEBAUT, MD, PhD USMR Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01485549     History of Changes
Other Study ID Numbers: CHUBX 2011/11
Study First Received: November 29, 2011
Last Updated: May 9, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Multiple system atrophy (MSA)
alpha-synucleinopathies
biological markers
cerebrospinal fluid
plasma

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014