Actively Recruiting
Study to Identify Predictive Factors of Onset and Progression of Parkinson Disease Using Clinical, Imaging, and Biological Markers
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-01-23
360
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
Sponsors
I
Institut National de la Santé Et de la Recherche Médicale, France
Lead Sponsor
I
IHU-A-ICM, Paris, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a four-year observational study to understand the clinical features, imaging results, and biological markers in people with Parkinson's disease (PD), as well as those at risk and healthy individuals. The study aims to identify markers that can predict the onset and progression of PD, which can be useful for future clinical trials focused on therapies that might modify the disease. Participants include newly diagnosed idiopathic PD patients, healthy controls, and individuals at risk of PD such as those with idiopathic REM sleep behavior disorder or genetic predisposition. All participants will be evaluated at the start and annually for four years. Assessments include motor, neuropsychiatric, sleep, eye, and cognitive evaluations, along with imaging scans. Biological samples such as blood (including DNA), stools, skin biopsies, and cerebrospinal fluid will also be collected. Throughout the study, participants will undergo detailed clinical, imaging, and laboratory assessments to track changes over time. Researchers will measure the rates of change in clinical signs and biomarkers annually for four years. This comprehensive follow-up will help monitor disease progression and identify useful predictors for PD onset and advancement.
CONDITIONS
Official Title
Cohort Study to Identify Predictor Factors of Onset and Progression of Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years and older
- Mini-Mental State Examination (MMSE) score greater than 26
- Negative pregnancy test for women who could become pregnant
- Idiopathic Parkinson disease diagnosed according to UK Parkinson's Disease Society Brain Bank criteria with disease duration less than 3 years
- Genetic Parkinson disease diagnosis with confirmed mutation in parkin, LRRK2, SNCA, or GBA genes
- Prodromal subjects with a relative with genetically confirmed Parkinson disease or diagnosis of idiopathic REM sleep Behavior Disorder with normal neurological exam
- Healthy subjects with normal neurological examination
You will not qualify if you...
- Psychiatric disorder or any progressive life-threatening disease
- Conditions preventing understanding or following study instructions
- Contraindications to MRI or SPECT scans
- Parkinson disease subjects without dopamine transporter deficit on SPECT scan
- Parkinsonism caused by neuroleptics or recent neuroleptic use within 6 months
- Atypical parkinson syndromes such as MSA, PSP, or CBD
- Parkinson disease subjects with genetic mutations having other atypical parkinson disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
- Current or recent use of neuroleptics within 6 months
- Any biological abnormalities
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
M
Marie VIDAILHET, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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