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 : February 26, 2019
|Condition or disease|
|Multiple System Atrophy (MSA)|
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.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|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|
Patients suffering from Multiple system atrophy (MSA)
Patients requiring spinal tap without being affected by a neurodegenerative disorder.
- Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (CSF). [ Time Frame: Day 0 ]
- 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 ]
- Alpha-synuclein levels in relation to disease duration and age [ Time Frame: Day 0 ]
Biospecimen Retention: Samples With DNA
- cerebrospinal fluid (CSF)
- whole blood
- blood serum
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
|Bordeaux University Hospital|
|Pessac, France, 33604|
|Principal Investigator:||Wassilios MEISSNER, MD, PhD||University Hospital, Bordeaux|
|Study Chair:||Rodolphe THIEBAUT, MD, PhD||USMR Bordeaux|