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

NCT ID: NCT02305147

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-06
• Study Completion Date: 2029-11-06

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) 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with an idiopathic Parkinson Disease,

Patients with recent onset of Parkinson Disease: N=200

No interventions assigned to this group

Subjects at risk of PD

Subjects at risk to develop Parkinson Disease:

• subjects with idiopathic Rem-sleep behavior disorder (iRBD): N=50
• subjects related to a patient with genetically confirmed Parkinson Disease: N=30

Clinical, biological and imaging followup

Intervention Type: OTHER

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.

Controls

Healthy controls: N=50

Clinical, biological and imaging followup

Intervention Type: OTHER

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.

Patients with Parkinson Disease with genetic mutation

Patients with Parkinson Disease with a genetic mutation in parkin, LRRK2, SNCA or GBA (N=30)

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IHU-A-ICM, Paris, France

UNKNOWN

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie VIDAILHET, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris, FRANCE

Jean-Christophe CORVOL, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris, FRANCE

Locations

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie VIDAILHET, PhD

Role: CONTACT

marie.vidailhet@psl.aphp.fr

Other Identifiers

C13-74

Identifier Type: -

Identifier Source: org_study_id