Oligomeric Alpha-synuclein in Multiple System Atrophy (BIOAMS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Multiple System Atrophy (MSA) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy |
- Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (CSF). [ Time Frame: CSF will be collected at inclusion (Day 0) and frozen. Analyses will be performed after last patient last visit (estimated date Jan-2014) ] [ Designated as safety issue: No ]
- Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF [ Time Frame: CSF will be collected at inclusion (Day 0) and frozen. Analyses will be performed after last patient last visit (estimated date Jan-2014) ] [ Designated as safety issue: No ]
- Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma [ Time Frame: CSF will be collected at inclusion (Day 0) and frozen. Analyses will be performed after last patient last visit (estimated date Jan-2014) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
- cerebrospinal fluid (CSF)
- whole blood
- plasma
- blood serum
- urine
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
MSA Patients
Patients suffering from Multiple system atrophy (MSA)
|
|
Controls
Patients requiring spinal tap without being affected by a neurodegenerative disorder.
|
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| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
MSA patients :
- Patients suffering from "probable" MSA according to clinical consensus criteria (Gilman et al, 2008)
- Age ≥ 30
- Written informed consent
- Patient covered by the French health insurance system
Controls :
- Patients not suffering from a neurodegenerative disorder and requiring a spinal tap
- Age ≥ 30
- Written informed consent
- Patient covered by the French health insurance system
Exclusion Criteria:
MSA patients :
- UMSARS IV score > 4 points
- Patient with coagulopathy, defined by an abnormal activated partial thromboplastin time or INR
- Patient with thrombocytopenia
- Patient under tutelage
- Patient unable to give consent
Controls :
- Patient with coagulopathy, defined by an abnormal activated partial thromboplastin time or INR
- Patient with thrombocytopenia
- Patient under tutelage
- Patient unable to give consent
Contacts and Locations| Contact: Wassilios MEISSNER, MD, PhD | (0)557656420 ext +33 | wassilios.meissner@chu-borfdeaux.fr |
| Contact: Olivier Flabeau, CCA | olivier.flabeau@chu-bordeaux.fr |
| France | |
| Bordeaux University Hospital | Recruiting |
| Pessac, France, 33604 | |
| Contact: Wassilios MEISSNER, MD, PhD (0)557656420 ext +33 wassilios.meissner@chu-bordeaux.fr | |
| Principal Investigator: Wassilios MEISSNER, MD, PhD | |
| Sub-Investigator: François TISON, MD, PhD | |
| Sub-Investigator: Anne-Cécile WIELANEK, MD | |
| Sub-Investigator: Olivier FLABEAU, MD | |
| Principal Investigator: | Wassilios MEISSNER, MD, PhD | University Hospital, Bordeaux |
| Study Chair: | Rodolphe THIEBAUT, MD, PhD | USMR Bordeaux |
More Information
No publications provided
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT01485549 History of Changes |
| Other Study ID Numbers: | CHUBX 2011/11 |
| Study First Received: | November 29, 2011 |
| Last Updated: | April 24, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Bordeaux:
|
Multiple system atrophy (MSA) alpha-synucleinopathies biological markers cerebrospinal fluid plasma |
Additional relevant MeSH terms:
|
Shy-Drager Syndrome Multiple System Atrophy Atrophy Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Hypotension Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013