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

Patrocinadores

Patrocinador principal: Institut National de la Santé Et de la Recherche Médicale, France

Colaborador: IHU-A-ICM, Paris, France

Fuente Institut National de la Santé Et de la Recherche Médicale, France
Resumen breve

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.

Descripción detallada

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.

Estado general Recruiting
Fecha de inicio November 6, 2014
Fecha de Terminación November 6, 2024
Fecha de finalización primaria November 6, 2019
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Rates of change of clinical, imaging and biomic outcomes 4 years (annual visits)
Resultado secundario
Medida Periodo de tiempo
Clinical milestones in PD patients 4 years (annual visits)
Prodromal features in subjects at risk to develop PD 4 years (annual visits)
Phenoconversion in subjects at risk to develop PD 4 years (annual visits)
Inscripción 360
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Clinical, biological and imaging followup

Descripción: 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.

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Contacto general

Apellido: Marie VIDAILHET, PhD

Email: [email protected]

Ubicación
Instalaciones: Estado: Hôpital Pitié-Salpêtrière
Ubicacion Paises

France

Fecha de verificación

December 2017

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Patients with an idiopathic Parkinson Disease,

Descripción: Patients with recent onset of Parkinson Disease: N=200

Etiqueta: Subjects at risk of PD

Descripción: 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

Etiqueta: Controls

Descripción: Healthy controls: N=50

Etiqueta: Patients with Parkinson Disease with genetic mutation

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

Acrónimo ICEBERG
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov