Oligomeric Alpha-synuclein in Multiple System Atrophy

Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01485549

Acronym

BIOAMS

Enrollment

Registered

2011-12-05

Start date

2012-11-26

Completion date

2018-11-21

Last updated

2019-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple System Atrophy (MSA)

Keywords

Multiple system atrophy (MSA), alpha-synucleinopathies, biological markers, cerebrospinal fluid, plasma

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results