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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

December 14, 2013
June 3, 2014
December 2013
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02016092 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Biomarker Discovery in Parkinson's Disease
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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.

Probability Sample

Parkinson's patients

Parkinson's Disease
Not Provided
  • Patients with Parkinson's disease
  • Healthy Controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Lori Sterling 408-542-5608 Lsterling@thepi.org
United States
 
NCT02016092
ECH-13-24, 5258
No
Birgitt Schuele, The Parkinson's Institute
The Parkinson's Institute
Not Provided
Not Provided
The Parkinson's Institute
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP