Status:
RECRUITING
Cohort Study to Identify Predictor Factors of Onset and Progression of Parkinson's Disease
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
IHU-A-ICM, Paris, France
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Brief Summary
Observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to healthy controls (HC) ...
Detailed Description
ICEBERG will be a four-year natural history study of de novo idiopathic PD patients, healthy controls, and subjects at risk to develop PD (idiopathic Rem Behavior Disorder -iRBD, and probants of patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 6 2029
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02305147
Start Date
November 6 2014
End Date
November 6 2029
Last Update
January 23 2025
Active Locations (1)
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1
Hôpital Pitié-Salpêtrière
Paris, France, 75013