Parkinson DiseaseNCT03384797
Blood Biomarker in Early Parkinson's Disease
An observational study of Parkinson Disease, run by Duke University at 1 site in United States.
Trial summary
Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 7 Jan 2019
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's patients will be recruited from the Duke Movement Disorders Clinic. Healthy adult volunteers will be recruited from the healthy volunteer registry at DEPRU or caregivers of patients seen at the Duke Movement Disorders Clinic.
Who may be able to join
- Age matched to PD patient Parkinson's Disease Patients:
- 50 years and older
- PD patient who is seen at the Duke Movement Disorders Center
- Early PD diagnosis (Hoehn and Yahr scale ≤ 3)
- Non-smoking
- No cancer treatment in the last 5 years
Show all 12Show fewer
- Able to read and speak English
- Healthy Control Participants:
- 50 years and older
- Non-smoking
- No cancer treatment in the last 5 years
- Able to read and speak English
Who cannot join
- Parkinson's Disease Patients:
- Known additional neurological disease
- Clinical trial intervention within the last 6 months
- Healthy Control Participants:
- Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)
- Clinical trial intervention within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Facility
Durham, North Carolina, 27710
About this study
Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for PD. Several detection parameters will be assessed through enrollment of Parkinson's patients and age matched healthy volunteers over 50 years of age to learn more about the analytical process and biological variability.
- Conditions
- Parkinson Disease
- Keywords
- blood, biomarker, Parkinson's disease
- 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 |
|---|---|---|
| Healthy Volunteers | Not described | |
| Parkinson's Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological marker of Parkinson's disease
Test for biological marker of Parkinson's disease, mtDNA damage
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start22 Jan 2018
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Sanders, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384797
- Sponsor's protocol ID
- Pro00088250
- Status last verified
- Jun 2019
- First submitted
- 20 Dec 2017
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Biomarker in Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03384797
- Acronym / sponsor ID
- Pro00088250
- Conditions
- Parkinson Disease
- Keywords
- blood, biomarker, Parkinson's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 27 Dec 2017 (actual)
- 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.
Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for PD. Several detection parameters will be assessed through enrollment of Parkinson's patients and age matched healthy volunteers over 50 years of age to learn more about the analytical process and biological variability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | – |
| Parkinson's Disease | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients will be recruited from the Duke Movement Disorders Clinic. Healthy adult volunteers will be recruited from the healthy volunteer registry at DEPRU or caregivers of patients seen at the Duke Movement Disorders Clinic.
Key inclusion criteria (12 listed)
- 50 years and older
- PD patient who is seen at the Duke Movement Disorders Center
- Early PD diagnosis (Hoehn and Yahr scale ≤ 3)
- Non-smoking
- No cancer treatment in the last 5 years
Key exclusion criteria (6 listed)
- Known additional neurological disease
- Clinical trial intervention within the last 6 months
- Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)
- Clinical trial intervention within the last 6 months
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 marker of Parkinson's disease
Time frame: Day 1
Test for biological marker of Parkinson's disease, mtDNA damage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Laurie Sanders, PhD principal investigator
Duke University
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 Disease, run by Duke University 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 12 inclusion and 6 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: finished, as of the sponsor's last update on 10 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 marker of Parkinson's disease (time frame: Day 1). 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 10 Jun 2019.