Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes

Emory University

Status: Completed

Conditions: Parkinson's Disease

Treatments: Other: Breath Sample Collection; Other: Blood Sample Collection

Study type: Observational

Funder types: Other

Identifiers

NCT02749214

IRB00086732

Details and patient eligibility

About

The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions.

The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.

Full description

The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions.

The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.

Investigators will determine how molecules in human breath can define a "breath signature" that can be associated with neurological disorders like Parkinson's disease. The long-term goal of this study is to use blood inflammatory marker relationships and Breath Analytical Approach to identify individuals at risk for development of neurologic disorders and to monitor the effects of immune interventions on the rate of disease progression.

The study team will recruit a total of 100 participants: 50 early stage (defined by a Hohn & Yahr Stages 1-2), non-smoking Parkinson's Disease patients from among the Emory Movement Disorders Clinic and 50 age and sex-matched healthy controls (HC). Investigators will recruit six to eight participants per month over an 18-month time period.

Enrollment: 100 patients

Sex: All

Ages: 25 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Participants with Parkinson's Disease (PD)

Inclusion Criteria:

• Must be capable of providing written informed consent
• Non-smoking
• Clinical diagnosis of PD Hohn & Yahr Stages 1 and 2

Exclusion Criteria:

• Cognitively impaired to the degree that they are not able to provide consent

Healthy Controls

Inclusion Criteria:

• Must be capable of providing written informed consent
• Age matched and a family member or healthy community control

Exclusion Criteria:

• Diagnosed with cancer and/or undergoing cancer treatment.

Trial design

100 participants in 2 patient groups

Parkinson's Disease (PD)

Description:

Participant's with Parkinson's Disease will provide peripheral blood and breath samples. Participants will also be asked to complete a neurologic exam and questionnaires.

Treatment:

Other: Breath Sample Collection

Other: Blood Sample Collection

Healthy Control

Description:

Age and gender-matched healthy controls will provide peripheral blood and breath samples. Participants will also be asked to complete a neurologic exam and questionnaires.

Treatment:

Other: Breath Sample Collection

Other: Blood Sample Collection