Biomarker Discovery in Parkinson's Disease

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02016092

Acronym

DISCOVERY-PD

Enrollment

400

Registered

2013-12-19

Start date

2013-12-31

Completion date

2016-06-30

Last updated

2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, biomarkers, blood, urine,, proteomics, lipidomics, metabolomics

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Biological markers of Parkinson's disease	18 months	To identify biologic markers of Parkinson's Disease (PD) for use in diagnostic testing.

Secondary

Measure	Time frame	Description
Correlation between biologic markers and clinical features of PD	36 months	To identify and investigate possible correlations between biologic markers and clinical features of PD.

Countries

United States

Outcome results