Clinical trial NCT02749214: Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
Official title: Defining a Parkinson's Disease (PD) -Specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2016-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a clinical diagnosis of Parkinson's Disease Hohn \& Yahr Stages 1 and 2 will be recruited from the Emory Movement and Disorders Clinic. Age and sex-matched healthy controls will also be recruited.

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale Subscale II Score
timeFrame: Up to 15 minutes
measure: Unified Parkinson's Disease Rating Scale Subscale III Score
timeFrame: Up to 15 minutes
measure: Modified Hoehn and Yahr Scale Score
timeFrame: Up to 15 minutes
measure: Overnight Questionnaire Score
timeFrame: Up to 15 minutes
measure: Beck's Depression Scale Score
timeFrame: Up to 15 minutes
measure: Montreal Cognitive Assessment (MOCA) Score
timeFrame: Up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Emory Clinic Executive Park
state: Georgia
Study officials:
affiliation: Emory University
name: Malu Tansey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hygieia, Inc
name: Charlene W Bayer, PhD
role: PRINCIPAL_INVESTIGATOR
References: