Parkinson's DiseaseDISCOVERY-PDNCT02016092
Biomarker Discovery in Parkinson's Disease
An observational study of Parkinson's Disease, run by The Parkinson's Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's patients
Who may be able to join
- 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
Who cannot join
- PD Subjects with any of the following may not be enrolled:
- Presence of atypical or secondary parkinsonism
- Inability to provide a blood and/or urine sample
- History of renal failure and/or on dialysis
- Currently taking a medication in the following categories: dopamine blockers, neuroleptics, and/or dopamine blocking agents.
- Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation
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- Healthy Controls:
- All of the following criteria must be met for a Healthy Control to be enrolled in the study:
- Healthy controls with no diagnosis of PD and any of the exclusion criteria
- Willing and able to give informed consent
- 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:
- No clinically significant or unstable medical or psychiatric condition that would interfere with the conduct of the study
- Diagnosis of PD or presence of signs of a neurodegenerative disorder, e.g. essential tremor
- First degree relative with PD/parkinsonism
- Inability to provide a blood and/or urine sample
- History of renal failure and/or on dialysis
- Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation
Trial locations and contacts
1 site in 1 country.
United States1 site
The Parkinson's Institute and Clinical Center
Sunnyvale, California, 94085
About this study
Official title: 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.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, biomarkers, blood, urine,, proteomics, lipidomics, metabolomics
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's disease | Not described | |
| Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological markers of Parkinson's disease
To identify biologic markers of Parkinson's Disease (PD) for use in diagnostic testing.
Measured: 18 months
Secondary outcomes (1)
Correlation between biologic markers and clinical features of PD
To identify and investigate possible correlations between biologic markers and clinical features of PD.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Parkinson's Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgitt Schuele, The Parkinson's Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016092
- Sponsor's protocol ID
- ECH-13-24
- Other IDs
- 5258
- Acronym
- DISCOVERY-PD
- Status last verified
- Mar 2016
- First submitted
- 14 Dec 2013
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available, summary datasets may be published in peer-review journals.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics, Metabolomics, Lipidomics and Genetic Analysis for Biomarker DISCOVERY in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02016092
- Acronym / sponsor ID
- DISCOVERY-PD / ECH-13-24
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, biomarkers, blood, urine,, proteomics, lipidomics, metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- The Parkinson's InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's disease | – | – |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- Presence of atypical or secondary parkinsonism
- Inability to provide a blood and/or urine sample
- History of renal failure and/or on dialysis
- Currently taking a medication in the following categories: dopamine blockers, neuroleptics, and/or dopamine blocking agents.
- Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biological markers of Parkinson's disease
Time frame: 18 months
To identify biologic markers of Parkinson's Disease (PD) for use in diagnostic testing.
1 secondary outcome
Correlation between biologic markers and clinical features of PD
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Individual participant dataSharing planned: No. Individual participant data will not be made available, summary datasets may be published in peer-review journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by The Parkinson's Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological markers of Parkinson's disease (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.