Clinical Trial: Oligomeric Alpha-synuclein in Multiple System Atrophy
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Observational
Official Title: Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy
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.
Detailed Summary:
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.
Sponsor: University Hospital, Bordeaux
Current Primary Outcome: 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) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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) ]
- 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) ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Bordeaux
Dates:
Date Received: November 29, 2011
Date Started: November 2012
Date Completion: November 2015
Last Updated: March 4, 2015
Last Verified: March 2015