Oligomeric Alpha-synuclein in Multiple System Atrophy (BIOAMS)

June 26, 2019 updated by: University Hospital, Bordeaux

Oligomeric Alpha-synuclein Levels as a Biomarker for 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.

Study Overview

Status

Completed

Conditions

Multiple System Atrophy (MSA)

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Pessac, France, 33604
    - Bordeaux University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
MSA Patients Patients suffering from Multiple system atrophy (MSA)
Controls Patients requiring spinal tap without being affected by a neurodegenerative disorder.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

Principal Investigator: Wassilios MEISSNER, MD, PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2012

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

November 21, 2018

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CHUBX 2011/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.