Biomarkers in Parkinsonian Syndromes (NCT02114242) | Clinical Trial Compass
UnknownNot Applicable
Biomarkers in Parkinsonian Syndromes
France100 participantsStarted 2013-12-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patients receiving anticoagulants, showing abnormal coagulation on blood testing or thrombocytopenia are excluded from this study.
Patients showing more than 500 erythrocytes per mm3 of LCR are excluded from this study.
* PD patients
* inclusion criteria:
* Patients suffering from PD according to clinical criteria (Hughes et al, 1992)
* Written informed consent
* Patient covered by the national health system
* exclusion criteria:
* Patient under tutelage
* patient covered by the national health system
* MSA patients
* inclusion criteria:
* 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
* exclusion criteria:
* UMSARS IV score \>4 points
* Patient under tutelage
* PSP patients
* inclusion criteria:
* 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:
* PSPRS item 26 score \>3 points
* Patient under tutelage
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of oligomeric alpha-synuclein in cerebrospinal fluid
Timeframe: at day 0 (inclusion) and one year after inclusion