Oligomeric Alpha-synuclein in Multiple System Atrophy

Completed

• Conditions: Multiple System Atrophy (MSA)

• Registration Number: NCT01485549
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Study Start: 2012-11-26
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (CSF).	Day 0

Secondary Outcome Measures

Name	Time	Method
Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF	Day 0
Alpha-synuclein levels in relation to disease duration and age	Day 0
Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma	Day 0

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Pessac, France