Idiopathic Parkinson DiseaseNCT03037463
Measuring Parkinson's Disease With Tear Fluid
An observational study of Idiopathic Parkinson Disease, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to assess whether tear secretion in patients with Parkinson's disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that will be reflected in changes in the protein composition of tear fluid, which can be measured relatively easily, cost-effectively, and… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Parkinson Disease
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Mar 2022
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will recruit participants with Parkinson's disease and controls from the Parkinson's Disease and Movement Disorder Center at the University of Southern California (USC) and from the surrounding community.
Who may be able to join
- established Parkinson's Disease for at least 6 months
- Healthy controls without neurological illness
Who cannot join
- currently taking anti-cholinergic medication
- dementia
- have an exposure to neuroleptic medications other than Quetiapine or Clozapine in the 6 months prior to screening
- have an active eye infection or have had eye surgery within 3 months prior to screening
- control subjects will be excluded if they have a history of neurological disease
- PD subjects will be excluded if they have an atypical Parkinsonian syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Identification of Tear Biomarkers for Parkinson's Disease Patients
The purpose of this study is to assess whether tear secretion in patients with Parkinson's disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that will be reflected in changes in the protein composition of tear fluid, which can be measured relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected from Parkinson's patients, and through biochemical assays, the profile of proteins in tears will be characterized and compared to that from control subjects. The profiles will be analyzed with respect to any differences between Parkinson's patients and control subjects. If differences appear, the levels of these potential biomarkers in Parkinson's patients will be compared to the severity of their disease.
- Conditions
- Idiopathic Parkinson 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 |
|---|---|---|
| Parkinson's Disease | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls
4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson 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
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Hamm-Alvarez, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037463
- Sponsor's protocol ID
- 11594
- Status last verified
- May 2022
- First submitted
- 12 Jan 2017
- Last updated
- 9 May 2022
- Results posted
- No
Publications
Hamm-Alvarez SF, Janga SR, Edman MC, Feigenbaum D, Freire D, Mack WJ, Okamoto CT, Lew MF. Levels of oligomeric alpha-Synuclein in reflex tears distinguish Parkinson's disease patients from healthy controls. Biomark Med. 2019 Dec;13(17):1447-1457. doi: 10.2217/bmm-2019-0315. Epub 2019 Sep 25.
PubMed 31552762
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Tear Biomarkers for Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT03037463
- Acronym / sponsor ID
- 11594
- Conditions
- Idiopathic Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 31 Jan 2017 (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.
The purpose of this study is to assess whether tear secretion in patients with Parkinson's disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that will be reflected in changes in the protein composition of tear fluid, which can be measured relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected from Parkinson's patients, and through biochemical assays, the profile of proteins in tears will be characterized and compared to that from control subjects. The profiles will be analyzed with respect to any differences between Parkinson's patients and control subjects. If differences appear, the levels of these potential biomarkers in Parkinson's patients will be compared to the severity of their disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | – |
| Control | – | – |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit participants with Parkinson's disease and controls from the Parkinson's Disease and Movement Disorder Center at the University of Southern California (USC) and from the surrounding community.
Key inclusion criteria (2 listed)
- established Parkinson's Disease for at least 6 months
- Healthy controls without neurological illness
Key exclusion criteria (6 listed)
- currently taking anti-cholinergic medication
- dementia
- have an exposure to neuroleptic medications other than Quetiapine or Clozapine in the 6 months prior to screening
- have an active eye infection or have had eye surgery within 3 months prior to screening
- control subjects will be excluded if they have a history of neurological disease
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
Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls
Time frame: up to 12 months
4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits
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 9 May 2022.
- Derived from this study: PubMed 31552762Hamm-Alvarez SF, Janga SR, Edman MC, Feigenbaum D, Freire D, Mack WJ, Okamoto CT, Lew MF. Levels of oligomeric alpha-Synuclein in reflex tears distinguish Parkinson's disease patients from healthy controls. Biomark Med. 2019 Dec;13(17):1447-1457. doi: 10.2217/bmm-2019-0315. Epub 2019 Sep 25.
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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 Idiopathic Parkinson Disease, run by University of Southern California 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 2 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 9 May 2022. 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?
Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037463, which also lists 1 linked publication.
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 9 May 2022.