Measuring Parkinson's Disease With Tear Fluid

NCT03037463 | Completed

• 1 other identifier: 11594
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 12 months

Study Arms (2)

Parkinson's Disease

Control

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• established Parkinson's Disease for at least 6 months
• Healthy controls without neurological illness

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• 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.

  PMID: 31552762 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair, Basic Research; Associate Dean, Basic and Translational Research; Director, Research development

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 31, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

US (1)