Oligomeric Alpha-synuclein in Multiple System Atrophy (BIOAMS)
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.
Multiple System Atrophy (MSA)
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy|
- 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 ]
- 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
- blood serum
|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)|
Patients suffering from Multiple system atrophy (MSA)
Patients requiring spinal tap without being affected by a neurodegenerative disorder.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485549
|Contact: Wassilios MEISSNER, MD, PhD||(0)557656420 ext +email@example.com|
|Contact: Olivier Flabeau, CCAfirstname.lastname@example.org|
|Bordeaux University Hospital||Recruiting|
|Pessac, France, 33604|
|Contact: Wassilios MEISSNER, MD, PhD (0)557656420 ext +33 email@example.com|
|Principal Investigator: Wassilios MEISSNER, MD, PhD|
|Sub-Investigator: François TISON, MD, PhD|
|Sub-Investigator: Anne-Cécile WIELANEK, MD|
|Sub-Investigator: Olivier FLABEAU, MD|
|Principal Investigator:||Wassilios MEISSNER, MD, PhD||University Hospital, Bordeaux|
|Study Chair:||Rodolphe THIEBAUT, MD, PhD||USMR Bordeaux|