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Oligomeric Alpha-synuclein in Multiple System Atrophy (BIOAMS)

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ClinicalTrials.gov Identifier: NCT01485549
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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 or disease
Multiple System Atrophy (MSA)

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.


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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy
Actual Study Start Date : November 26, 2012
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
MSA Patients
Patients suffering from Multiple system atrophy (MSA)
Controls
Patients requiring spinal tap without being affected by a neurodegenerative disorder.



Primary Outcome Measures :
  1. Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (CSF). [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF [ Time Frame: Day 0 ]
  2. Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma [ Time Frame: Day 0 ]
  3. Alpha-synuclein levels in relation to disease duration and age [ Time Frame: Day 0 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
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
  • MSA patients

    o 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

    o exclusion criteria: UMSARS IV score > 4 points Patient under tutelage Patient unable to give consent Patients receiving anticoagulants, showing abnormal coagulation on blood testing or thrombocytopenia are excluded from this study

  • Controls (patients requiring spinal tap without suffering from a neurodegenerative disorder) o Inclusion criteria: Patients not suffering from a neurodegenerative disorder and requiring a spinal tap Age >30 Written informed consent Patient covered by the national health system o exclusion criteria: Similar to MSA patients

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


Locations
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France
Bordeaux University Hospital
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Wassilios MEISSNER, MD, PhD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01485549     History of Changes
Other Study ID Numbers: CHUBX 2011/11
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: February 2019
Keywords provided by University Hospital, Bordeaux:
Multiple system atrophy (MSA)
alpha-synucleinopathies
biological markers
cerebrospinal fluid
plasma
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
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