Biomarkers in Parkinsonian Syndromes

NCT02114242 | Unknown

• 1 other identifier: CHUBX 2012/27
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates in PSP. The development of biological markers for the diagnosis and prognosis in PD, MSA and PSP 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 PD and MSA. The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies. The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood sampling at two study visits (baseline and after 12 months). Major secondary objectives are (i) to assess potential associations between the biomarker and clinical measures of disease severity and progression in MSA and PSP, and (ii) to assess the variation of the biomarker and its correlation to disease severity and progression in PD, MSA and PSP.

Conditions

Parkinsonian Syndromes; Parkinson's Disease; Multiple System Atrophy; Progressive Supranuclear Palsy

Keywords

Parkinson's disease; multiple system atrophy; progressive supranuclear palsy; alpha-synuclein

Outcome Measures

Primary Outcomes (1)

• Concentration of oligomeric alpha-synuclein in cerebrospinal fluid

  at day 0 (inclusion) and one year after inclusion

Secondary Outcomes (4)

• Total alpha-synuclein concentration in CSF, oligomeric/total alpha-synuclein ratio in CSF

  At inclusion (Day 0) and one year after inclusion

• Oligomeric and total alpha-synuclein concentration in plasma, oligomeric/total alpha-synuclein ratio in plasma

  At inclusion (Day 0) and one year after inclusion

• Alpha-synuclein levels in relation to disease severity and progression, disease duration and age

  At inclusion (Day 0) and one year after inclusion

• Variation of alpha-synuclein levels between first and second sampling

  At inclusion (Day 0) and one year after inclusion

Study Arms (3)

Parkinson's disease patients

Patients suffering from Parkinson desease

Other: clinical measures of disease severity and progression

multiple system atrophy patients

Patients suffering from "probable" multiple system atrophy according to clinical consensus criteria and age \> 30

Other: CSF, blood and urine sampling; Other: clinical measures of disease severity and progression

progressive supranuclear palsy

Patients suffering from progressive supranuclear palsy and age \> 40

Other: CSF, blood and urine sampling; Other: clinical measures of disease severity and progression

Interventions

CSF, blood and urine sampling OTHER

PSP and MSA patients will receive CSF and blood sampling at two study visits (baseline and after 12 months).

multiple system atrophy patients; progressive supranuclear palsy

clinical measures of disease severity and progression OTHER

Questionnaires (quality of life, motricity scales, cognitive scales, depression scales, scale of sleep quality)

Parkinson's disease patients; multiple system atrophy patients; progressive supranuclear palsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from parkinson disease or multiple system atrophy or progressive supranuclear palsy.

You may qualify if:

• Patients suffering from PD according to clinical criteria (Hughes et al, 1992)
• Written informed consent
• Patient covered by the national health system

You may not qualify if:

• Patient under tutelage
• patient covered by the national health system
• MSA patients
• Patients suffering from "possible" or "probable" MSA according to clinical consensus criteria (Gilman et al, 2008), age \> 30
• Written informed consent
• Patient covered by the national health system
• UMSARS IV score \>4 points
• Patient under tutelage
• PSP patients
• Patients suffering from PSP according to NNIPPS trial criteria (Bensimon et al., 2009), age \> 40
• Written informed consent
• Patient covered by the national health system
• PSPRS item 26 score \>3 points
• Patient under tutelage

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (3)

CHU de Limoges

Limoges, 87000, France

RECRUITING

CHU de Bordeaux

Pessac, 33640, France

RECRUITING

CHU de Toulouse

Toulouse, 31000, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Cerebrospinal fluid * Whole blood * Plasma * Serum * Urine

MeSH Terms

Conditions

Parkinsonian Disorders; Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Wassilios MEISSNER, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Rodolphe THIEBAUT, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Central Study Contacts

Wassilios MEISSNER, Pr

CONTACT

wassilios.meissner@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: April 15, 2014
• Study Start: December 16, 2013
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2025
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

FR (3)