Clinical trial NCT02016092: Biomarker Discovery in Parkinson's Disease
Official title: Proteomics, Metabolomics, Lipidomics and Genetic Analysis for Biomarker DISCOVERY in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
biomarkers
blood
urine,
proteomics
lipidomics
metabolomics
Lead sponsor: The Parkinson's Institute
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson's patients

Brief 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.


Eligibility 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, 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

Primary outcomes:
measure: Biological markers of Parkinson's disease
timeFrame: 18 months
Secondary outcomes:
measure: Correlation between biologic markers and clinical features of PD
timeFrame: 36 months
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: The Parkinson's Institute and Clinical Center
state: California
Study officials:
References: