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

Parkinson Disease Clinical Trial

— ICEBERG  

Official title:

Etude Des Facteurs prédictifs de l'Apparition et de l'évolution de la Maladie de Parkinson

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02305147
• Other study ID #: C13-74
• Status: Recruiting
• Phase: N/A
• First received: October 10, 2014
• Last updated: December 5, 2017
• Start date: November 6, 2014
• Est. completion date: November 6, 2024

Study information

• Verified date: December 2017
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Marie VIDAILHET, PhD
• Email: marie.vidailhet[@]psl.aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 6, 2024
• Est. primary completion date: November 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Pitié-Salpêtrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	IHU-A-ICM, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of change of clinical, imaging and biomic outcomes	Slopes of change of clinical, imaging and biomics compared between PD patients, subjects at risk to develop PD and healthy subjects.; Identification of predictive factors of these rates of change. As examples, outcomes include: MDS-UPDRS, Mattis dementia rating scale, Non Motor Signs scale, DAT striatal uptake.	4 years (annual visits)
Secondary	Clinical milestones in PD patients	Occurence of complications such as falls, freezing, dyskinesias, motor fluctuations, cognitive impairment, dysautonomia.; Identification of predictive factors of these complications. Rates of progression in sub-groups of patients defined by the presence of these complications.	4 years (annual visits)
Secondary	Prodromal features in subjects at risk to develop PD	Prodromal features such as anosmia, dysautonomia, color vision impairment, will be evaluated at inclusion and during followup in subjects with iRBD or first-degree relatives of genetically confirmed PD patients.; Frequency of these features will be compared between subjects who phenoconvert and those who don't.; Relation between baseline DatSCAN binding and risk of phenoconversion will be analysed.	4 years (annual visits)
Secondary	Phenoconversion in subjects at risk to develop PD	Phenoconversion is defined as occurence of an extrapyramidal syndrome, confirmed 12 months later.; Exploratory analysis to determine whether rates of progression clinical, imaging and biomic markers may predict phenoconversion in groups of patients with iRBD or probants of patients with PD genetically confirmed.	4 years (annual visits)