Non-invasive Detection of Volatile Metabolites in Parkinson's Disease

NCT06453226 | Recruiting

• 2 other identifiers: 31157722/NI/0090
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is the second most common neurodegenerative disorder. Currently, a diagnostic test for early PD does not exist. The aim to address this problem by developing a non-invasive breath test to differentiate early PD from controls. Small molecules contained in breath, which offers precious information about disease presence, will be analysed. Data from the breath molecules and gut bacterial changes occurring in PD will be combined. These bacterial changes have been shown to arise years before the development of PD symptoms. Thanks to earlier diagnosis, therapies could start in advance and improve clinical outcomes and quality of life.

Conditions

Parkinson Disease

Keywords

volatile organic compounds

Outcome Measures

Primary Outcomes (1)

• Identification of biomarker and measurement of their levels for the development of a non-invasive breath test for Parkinson's diagnosis

  The primary outcome is the identification of biomarkers and measurement of their levels in breath for the future development of a non-invasive breath test, able to diagnose Parkinson's disease. These levels will be measured using gas chromatography mass spectrometry. Differences will be identified in Parkinson's group vs de-novo and healthy controls and important compounds will be therefore identified.

  June 2025

Secondary Outcomes (1)

• Characterisation of microbiome in Parkinson patients, de novo and healthy controls

  June 2025

Study Arms (3)

Parkinson's group

Patients with confirmed Parkinson's disease undergoing neurological examination

Healthy Controls

Patients will be asked to nominate a partner/carer that can be enrolled in the control group. Healthy controls will also be recruited using web-based adverts mainly via the Imperial Clinical Research Facility and Parkinson's disease charities.

De-Novo

Patients undergoing neurological examination for suspected Parkinson's disease due to presence of symptoms

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population for this study will be divided in three groups: (i) Parkinson patients (ii) healthy controls (iii) de-novo patients.

You may qualify if:

• (i) Patients undergoing neurological examination for confirmed or suspected Parkinson's disease
• (ii) Patients aged ≥18 years and below 90 years of age;
• (iii) Patients off antibiotic or probiotic therapies for at least the last 4 weeks;
• (iv) Patients without formal diagnosis of dysbiotic conditions;
• (v) Patients with capacity.
• (i) healthy volunteers that may be or not partner or carer of a Parkinson's patient;
• (ii) Subject aged ≥18 years and below 90 years of age;
• (iii) Patients off antibiotic or probiotic therapies for at least the last 4 weeks;
• (iv) Patients without formal diagnosis of dysbiotic conditions;
• (iiv) Subject with capacity.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Charing Cross Hospital, Imperial College London

London, W12 0NN, United Kingdom

RECRUITING

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

Central Study Contacts

Ilaria Belluomo, Dr

CONTACT

020 7589 5111; i.belluomo@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 11, 2024
• Study Start: January 25, 2023
• Primary Completion: June 30, 2024
• Study Completion: January 30, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

GB (1)