Clinical trial NCT01485549: Oligomeric Alpha-synuclein in Multiple System Atrophy
Official title: Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple System Atrophy (MSA)
Keywords: Multiple system atrophy (MSA)
alpha-synucleinopathies
biological markers
cerebrospinal fluid
plasma
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (CSF).
timeFrame: Day 0
Secondary outcomes:
measure: Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF
timeFrame: Day 0
measure: Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma
timeFrame: Day 0
measure: Alpha-synuclein levels in relation to disease duration and age
timeFrame: Day 0
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Wassilios MEISSNER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: