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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Birgitt Schuele, The Parkinson's Institute
ClinicalTrials.gov Identifier:
NCT02016092
First received: December 14, 2013
Last updated: March 10, 2016
Last verified: March 2016

December 14, 2013
March 10, 2016
December 2013
March 2016   (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.
 
Active, not recruiting
400
June 2016
March 2016   (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, 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
Both
18 Years to 90 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02016092
ECH-13-24, 5258
No
No
Individual participant data will not be made available, summary datasets may be published in peer-review journals.
Birgitt Schuele, The Parkinson's Institute
The Parkinson's Institute
Not Provided
Not Provided
The Parkinson's Institute
March 2016

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