Biomarker Discovery in Parkinson's Disease

NCT02016092 | Unknown

• 2 other identifiers: ECH-13-245258
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Biological markers of Parkinson's disease

  To identify biologic markers of Parkinson's Disease (PD) for use in diagnostic testing.

  18 months

Secondary Outcomes (1)

• Correlation between biologic markers and clinical features of PD

  36 months

Study Arms (2)

Patients with Parkinson's disease

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Parkinson's patients

You may qualify if:

• For PD cases:
• 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

You may not qualify if:

• PD Subjects with any of the following may not be enrolled:
• Presence of atypical or secondary parkinsonism
• Inability to provide a blood and/or urine sample
• History of renal failure and/or on dialysis
• Currently taking a medication in the following categories: dopamine blockers, neuroleptics, and/or dopamine blocking agents.
• 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:
• Willing and able to give informed consent
• 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:
• No clinically significant or unstable medical or psychiatric condition that would interfere with the conduct of the study
• Diagnosis of PD or presence of signs of a neurodegenerative disorder, e.g. essential tremor
• First degree relative with PD/parkinsonism
• Inability to provide a blood and/or urine sample

Sponsors & Collaborators

• The Parkinson's Institute: lead

Study Sites (1)

The Parkinson's Institute and Clinical Center

Sunnyvale, California, 94085, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood \& Urine Specimen Collection: Up to 20mL of venous blood samples will be collected for plasma multi-omic analysis, as well as optional genetic, analyses. Urine samples (\~50ml) will be collected via sterile urine cup and transferred into appropriate urine tube for multi-omic analysis. All Samples may be saved for future studies, if consented.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 14, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 14, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)