Biomarker Discovery in Parkinson's Disease
Status: | Active, not recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 90 |
Updated: | 4/21/2016 |
Start Date: | December 2013 |
End Date: | June 2016 |
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.
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.
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
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