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Oligomeric Alpha-synuclein in Multiple System Atrophy (BIOAMS)

This study is currently recruiting participants.
Verified November 2017 by University Hospital, Bordeaux
Sponsor:
ClinicalTrials.gov Identifier:
NCT01485549
First Posted: December 5, 2011
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Bordeaux
  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: Day 0 ]

Secondary Outcome Measures:
  • Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF [ Time Frame: Day 0 ]
  • Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma [ Time Frame: Day 0 ]

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

Estimated Enrollment: 40
Actual Study Start Date: November 26, 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (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

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 and controls :

    • 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
    • Pregnant or breastfeeding women
    • Pathology leading to necrosis of the cerebral tissue
    • Significant anomaly of standard markers of Cerebrospinal fluid (CSF)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01485549     History of Changes
Other Study ID Numbers: CHUBX 2011/11
First Submitted: November 29, 2011
First Posted: December 5, 2011
Last Update Posted: November 13, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Pathological Conditions, Anatomical
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