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Completed

NCT Number: NCT01485549

Oligomeric Alpha-synuclein in Multiple System Atrophy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (CSF).

    Time frame: Day 0

Secondary outcomes

  1. Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF

    Time frame: Day 0

  2. Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma

    Time frame: Day 0

  3. Alpha-synuclein levels in relation to disease duration and age

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: BIOAMS

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2011
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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