Biomarker Discovery in Parkinson's Disease

Proteomics, Metabolomics, Lipidomics and Genetic Analysis for Biomarker DISCOVERY in Parkinson's Disease

Patrocinadores

Patrocinador principal: The Parkinson's Institute

Fuente The Parkinson's Institute
Resumen breve

There are approximately one million Americans who live with Parkinson's disease with 50,000 new cases per year and this rate is expected to rise with an aging population. The underlying pathophysiology and disease understanding of PD still remains elusive due to a combination of disease complexity and lack of predictive capability of existing models.

The Berg Interrogative Biology™ discovery platform has demonstrated a unique capability in producing drug targets and biomarkers that truly represent a disease phenotype. It has been able to catalyze molecules now in late stage clinical trials in cancer and many pre-clinical candidate therapeutics and biomarkers in endocrinology and central nervous system (CNS) diseases. The platform is able to decipher normal versus disease signatures by integration of data sets from the genome, metabolome, proteome, and lipidome in an agnostic manner that is subjected to Bayesian Artificial Intelligence informatics. The resulting nodes are then put back into wet-lab validation before proceeding to proof-of-principle pre-clinical testing.

By utilizing clinical data and specimens obtained by the medical specialists at The Parkinson's Institute, along with Berg's Interrogative Biology™, this study aims to discover a disease biomarker enabling the creation of a diagnostic test for Parkinson's disease.

Estado general Unknown status
Fecha de inicio December 2013
Fecha de Terminación June 2016
Fecha de finalización primaria March 2016
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Biological markers of Parkinson's disease 18 months
Resultado secundario
Medida Periodo de tiempo
Correlation between biologic markers and clinical features of PD 36 months
Inscripción 400
Condición
Elegibilidad

Método de muestreo: Probability Sample

Criterios:

Inclusion Criteria:

For PD cases:

Inclusion Criteria:

- Men and women with the clinical diagnosis of idiopathic PD

- Willing and able to give informed consent

- Willing and able to comply with scheduled visits, required study procedures and laboratory tests

Exclusion Criteria:

PD Subjects with any of the following may not be enrolled:

1. Presence of atypical or secondary parkinsonism

2. Inability to provide a blood and/or urine sample

3. History of renal failure and/or on dialysis

4. Currently taking a medication in the following categories: dopamine blockers, neuroleptics, and/or dopamine blocking agents.

5. Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation

Healthy Controls:

All of the following criteria must be met for a Healthy Control to be enrolled in the study:

1. Healthy controls with no diagnosis of PD and any of the exclusion criteria

2. Willing and able to give informed consent

3. Willing and able to comply with scheduled visits, required study procedures and laboratory tests

Healthy Controls with any of the following may not be enrolled:

1. No clinically significant or unstable medical or psychiatric condition that would interfere with the conduct of the study

2. Diagnosis of PD or presence of signs of a neurodegenerative disorder, e.g. essential tremor

3. First degree relative with PD/parkinsonism

4. Inability to provide a blood and/or urine sample

5. History of renal failure and/or on dialysis

6. Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation

Género: All

Edad mínima: 18 Years

Edad máxima: 90 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Ubicación
Instalaciones: The Parkinson's Institute and Clinical Center
Ubicacion Paises

United States

Fecha de verificación

March 2016

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: The Parkinson's Institute

Nombre completo del investigador: Birgitt Schuele

Título del investigador: Associate Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Patients with Parkinson's disease

Etiqueta: Healthy Controls

Acrónimo DISCOVERY-PD
Datos del paciente No
Información de diseño del estudio

Modelo de observación: Case-Control

Perspectiva de tiempo: Cross-Sectional

Fuente: ClinicalTrials.gov