Biomarkers in Parkinsonian Syndromes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-16

Study Completion Date

2025-12-16

Brief Summary

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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.

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Detailed Description

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The differential diagnosis between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy can be very difficult in early disease. PD, MSA and PSP are neurodegenerative disorders. PD and MSA belong to the alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. Alpha-synuclein accumulates in intraneuronal Lewy bodies in PD patients and as intracytoplasmic glial inclusions in MSA. In PSP, tau protein accumulates in neurons and glia cells while alpha-synuclein deposits are only found to a small extend.

The development of biological markers for the diagnosis and prognosis of PD, MSA and PSP remains an unmet need. Beyond guiding clinical decision-making, 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 of PD and MSA. The oligomeric alpha-synuclein fraction whose CSF levels are increased in PD seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.

The main objective of the study is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. Secondary objectives are (i) to compare total alpha-synuclein levels and the index total/oligomeric alpha-synuclein between PD, MSA and PSP, (ii) to study the correlation and concordance between CSF and plasma levels of total and oligomeric alpha-synuclein, (iii) to assess potential associations between the biomarker and clinical measures of disease severity and progression and (iv) to assess the variation of the biomarker over time and its correlation to disease severity and progression.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson's disease patients

Patients suffering from Parkinson desease

clinical measures of disease severity and progression

Intervention Type OTHER

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

multiple system atrophy patients

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

CSF, blood and urine sampling

Intervention Type OTHER

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

clinical measures of disease severity and progression

Intervention Type OTHER

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

progressive supranuclear palsy

Patients suffering from progressive supranuclear palsy and age \> 40

CSF, blood and urine sampling

Intervention Type OTHER

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

clinical measures of disease severity and progression

Intervention Type OTHER

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

Interventions

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CSF, blood and urine sampling

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

Intervention Type OTHER

clinical measures of disease severity and progression

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

* 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

* 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

Exclusion Criteria

Patients showing more than 500 erythrocytes per mm3 of LCR are excluded from this study.

* PD patients

* Patient under tutelage
* patient covered by the national health system
* MSA patients

* UMSARS IV score \>4 points
* Patient under tutelage
* PSP patients

* PSPRS item 26 score \>3 points
* Patient under tutelage

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No