Biomarker Discovery in Parkinson's Disease

Parkinson's Disease Clinical Trial

— DISCOVERY-PD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02016092
• Other study ID #: ECH-13-24
• Secondary ID: 5258
• Status: Active, not recruiting
• Phase: N/A
• First received: December 14, 2013
• Last updated: March 10, 2016
• Start date: December 2013
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: The Parkinson's Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	The Parkinson's Institute and Clinical Center	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
The Parkinson's Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological markers of Parkinson's disease	To identify biologic markers of Parkinson's Disease (PD) for use in diagnostic testing.	18 months	No
Secondary	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	No