Identifying factors that predict the onset and progression of Parkinson's Disease
Etude Des Facteurs Prédictifs De L'apparition Et De L'évolution De La Maladie De Parkinson
This study is trying to find out what signs and factors can help predict how Parkinson's Disease starts and progresses in patients compared to healthy people and those at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Paris) |
| Trial ID | NCT02305147 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess clinical features, imaging, and biological biomarkers in patients with Parkinson's Disease (PD) and compare their progression to healthy controls and individuals at risk of developing PD. Over four years, participants will undergo comprehensive evaluations, including motor, neuropsychiatric, sleep, ocular, and cognitive assessments, along with the collection of various biological samples. The primary goal is to identify markers that can be used in future clinical trials for disease-modifying therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with idiopathic Parkinson's Disease, genetic forms of Parkinson's, prodromal features, or healthy individuals with normal neurological examinations.
Not a fit: Patients with psychiatric disorders or other progressive life-threatening diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of Parkinson's Disease through the identification of predictive biomarkers.
How similar studies have performed: Other studies have shown success in identifying biomarkers for Parkinson's Disease, but this specific approach is novel in its comprehensive assessment of multiple factors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All subjects: Male or female age 18 years and older, MMSE score \> 26, negative pregnancy test in potentially child-bearing women (contraindication to SPECT with DatScan). * Idiopathic Parkinson disease subjects: diagnosis confirmed according to UK Parkinson's Disease Society Brain Bank criteria (UKPDSBB); disease duration less than 3 years. * Genetic Parkinson disease subjects: parkinson diagnosis confirmed and mutation in parkin, LRRK2, SNCA or GBA genes. * Prodromal subjects: subjects with identified relative with PD genetically confirmed or subjects with diagnosis of idiopathic Rem sleep Behavior Disorder (iRBD); neurological examination normal (no signs of parkinsonism). * Healthy subjects: neurological examination normal Exclusion Criteria: * All subjects: Psychiatric disorder or any progressive life-threatening disease, impairment precluding appropriate information and instructions given concerning participation to the study; contra-indication to MRI or SPECT scan. * Parkinson disease subjects: no dopamine transporter deficit at SPECT scan; parkinsonism induced by neuroleptics; neuroleptics intake within 6 months; atypical parkinson syndrom (MSA, PSP, CBD...) * Parkinson disease subjects with mutation in Parkin, LRRK2, SNCA or GBA gene: atypical parkinson disease syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy) or currently taking neuroleptics or has taken neuroleptics within 6 months of baseline or any biological anomaly.
Where this trial is running
Paris
- Hôpital Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Marie VIDAILHET, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Marie VIDAILHET, PhD
- Email: marie.vidailhet@psl.aphp.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.