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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The Parkinson's Institute
Sponsor:
Information provided by (Responsible Party):
Birgitt Schuele, The Parkinson's Institute
ClinicalTrials.gov Identifier:
NCT02016092
First received: December 14, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Proteomics, Metabolomics, Lipidomics and Genetic Analysis for Biomarker DISCOVERY in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by The Parkinson's Institute:

Primary Outcome Measures:
  • Biological markers of Parkinson's disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To identify biologic markers of Parkinson's Disease (PD) for use in diagnostic testing.


Secondary Outcome Measures:
  • Correlation between biologic markers and clinical features of PD [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    To identify and investigate possible correlations between biologic markers and clinical features of PD.


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.


Estimated Enrollment: 400
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Parkinson's disease
Healthy Controls

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Parkinson's patients

Criteria

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
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016092

Contacts
Contact: Lori Sterling 408-542-5608 Lsterling@thepi.org

Locations
United States, California
The Parkinson's Institute and Clinical Center Recruiting
Sunnyvale, California, United States, 94085
Contact: Lori Sterling    408-542-5608    lsterling@thepi.org   
Principal Investigator: Birgitt Schuele, MD         
Sponsors and Collaborators
The Parkinson's Institute
  More Information

No publications provided

Responsible Party: Birgitt Schuele, Associate Professor, The Parkinson's Institute
ClinicalTrials.gov Identifier: NCT02016092     History of Changes
Other Study ID Numbers: ECH-13-24, 5258
Study First Received: December 14, 2013
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Parkinson's Institute:
Parkinson's disease
biomarkers
blood
urine,
proteomics
lipidomics
metabolomics

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 20, 2014