Biomarker Discovery in Parkinson's Disease

NCT ID: NCT02016092

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Parkinson's Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with Parkinson's disease

No interventions assigned to this group

Healthy Controls

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

For PD cases:

• 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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Parkinson's Institute

OTHER

Sponsor Role: lead

Responsible Party

Birgitt Schuele

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Parkinson's Institute and Clinical Center

Sunnyvale, California, United States

Countries

United States

Other Identifiers

5258

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ECH-13-24

Identifier Type: -

Identifier Source: org_study_id