Biomarker Discovery in Parkinson's Disease (DISCOVERY-PD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • California
    • Sunnyvale, California, United States, 94085
      • The Parkinson's Institute and Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Parkinson's patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Controls
Patients with Parkinson's disease

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Parkinson's Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: December 14, 2013
• First Submitted That Met QC Criteria: December 14, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: biomarkers; blood; Parkinson's disease; metabolomics; lipidomics; proteomics; urine,
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: ECH-13-24; 5258 (Other Grant/Funding Number: Berg Pharma, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available, summary datasets may be published in peer-review journals.