Investigating biomarkers in Parkinson's disease and related disorders
Development of Biomarkers for the Diagnosis and Prognosis of Parkinsonian Syndromes Running Head: Biomarkers in Parkinsonian Syndromes
This study is trying to see if measuring certain proteins in the spinal fluid can help doctors better diagnose and understand Parkinson's disease and similar disorders.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 3 sites (Limoges and 2 other locations) |
| Trial ID | NCT02114242 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare levels of oligomeric alpha-synuclein in cerebrospinal fluid (CSF) among patients with Parkinson's disease (PD), multiple system atrophy (MSA), and progressive supranuclear palsy (PSP). Participants will undergo CSF and blood sampling at two visits, one at baseline and another after 12 months. The study seeks to develop biological markers that can aid in the diagnosis and prognosis of these neurodegenerative disorders, which currently lack effective differentiation methods. By understanding the levels of alpha-synuclein and tau proteins, the research hopes to contribute to future disease-modification and neuroprotection trials.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease, multiple system atrophy, or progressive supranuclear palsy who are over 30 years old and can provide informed consent.
Not a fit: Patients with severe coagulation issues or those under legal guardianship may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and treatment strategies for patients with Parkinsonian syndromes.
How similar studies have performed: Other studies have shown promise in developing biomarkers for neurodegenerative diseases, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Limoges and 2 other locations
- CHU de Limoges — Limoges, France (Recruiting)
- CHU de Bordeaux — Pessac, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Wassilios MEISSNER, Pr — University Hospital, Bordeaux
- Study coordinator: Wassilios MEISSNER, Pr
- Email: wassilios.meissner@chu-bordeaux.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.