NCT02305147

Cohort Study to Identify Predictor Factors of Onset and Progression of Parkinson's Disease

Etude Des Facteurs Prédictifs De L'apparition Et De L'évolution De La Maladie De Parkinson

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 360 (estimated)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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) and subjects at risk to develop PD. The primary objective of this study is to identify clinical, imaging and biologic markers of PD onset and progression for use in clinical trials of disease-modifying therapies.

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 patients with PD genetically confirmed). All subjects will be comprehensively assessed at baseline and every year thereafter. Subjects will undergo clinical (motor, neuropsychiatric, sleep, ocular and cognitive evaluations) and imaging assessments. Blood (including a DNA sample), stools, skin biopsy and cerebral spinal fluid (CSF) samples will be collected.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Clinical, biological and imaging followup	Assessment of motor and non motor signs every 12 months. Imaging and blood, cerebral fluid, stools and skin samples for identification of biomarkers of disease phenotype and progression.

Timeline

• Start date: 2014-11-06
• Primary completion: 2029-11-06
• Completion: 2029-11-06
• First posted: 2014-12-02
• Last updated: 2025-01-23

Locations

1 site across 1 country: France