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Oligomeric Alpha-synuclein in Multiple System Atrophy (BIOAMS)

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ClinicalTrials.gov Identifier: NCT01485549
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date November 29, 2011
First Posted Date December 5, 2011
Last Update Posted Date June 27, 2019
Actual Study Start Date November 26, 2012
Actual Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 9, 2017)
Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (CSF). [ Time Frame: Day 0 ]
Original Primary Outcome Measures
 (submitted: December 1, 2011)
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) ]
Change History Complete list of historical versions of study NCT01485549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 22, 2019)
  • Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF [ Time Frame: Day 0 ]
  • Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma [ Time Frame: Day 0 ]
  • Alpha-synuclein levels in relation to disease duration and age [ Time Frame: Day 0 ]
Original Secondary Outcome Measures
 (submitted: December 1, 2011)
  • 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) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oligomeric Alpha-synuclein in Multiple System Atrophy
Official Title Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • cerebrospinal fluid (CSF)
  • whole blood
  • plasma
  • blood serum
  • urine
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.

Condition Multiple System Atrophy (MSA)
Intervention Not Provided
Study Groups/Cohorts
  • MSA Patients
    Patients suffering from Multiple system atrophy (MSA)
  • Controls
    Patients requiring spinal tap without being affected by a neurodegenerative disorder.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 22, 2019)
48
Original Estimated Enrollment
 (submitted: December 1, 2011)
40
Actual Study Completion Date November 21, 2018
Actual Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01485549
Other Study ID Numbers CHUBX 2011/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators
Principal Investigator: Wassilios MEISSNER, MD, PhD University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date February 2019