Overview

This trial is active, not recruiting.

Condition parkinson's disease
Sponsor The Parkinson's Institute
Start date December 2013
End date March 2016
Trial size 400 participants
Trial identifier NCT02016092, 5258, ECH-13-24

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm

Primary Outcomes

Measure
Biological markers of Parkinson's disease
time frame: 18 months

Secondary Outcomes

Measure
Correlation between biologic markers and clinical features of PD
time frame: 36 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Proteomics, Metabolomics, Lipidomics and Genetic Analysis for Biomarker DISCOVERY in Parkinson's Disease
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by The Parkinson's Institute.