Identifying early biomarkers for Parkinson's disease and related disorders using olfactory mucosa, blood, and urine samples
Exploring the Olfactory Mucosa, Blood and Urine for the Identification of Early Biomarkers of Parkinson's Disease, Atypical Parkinsonisms and Neurocognitive Disorders Due to Lewy Body Disease
This study is testing if samples from the nose, blood, and urine can help doctors find early signs of Parkinson's disease and related disorders more accurately.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 3 sites (Sesto Fiorentino, FI and 2 other locations) |
| Trial ID | NCT06846658 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the diagnosis of Parkinson's disease, multiple system atrophy, and dementia with Lewy bodies by identifying specific biomarkers in olfactory mucosa, blood, and urine. Utilizing advanced techniques such as RT-QuIC, Simoa SR-X, ELISA, and NTA, the researchers will analyze these samples to detect misfolded alpha-synuclein aggregates associated with these conditions. The study combines expertise from various fields, including neurology and machine learning, to develop a comprehensive approach for biomarker detection and characterization. By focusing on non-invasive sample collection, the study seeks to enhance early diagnosis and patient stratification.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, or other related neurodegenerative disorders.
Not a fit: Patients with conditions unrelated to alpha-synucleinopathies or those who do not exhibit symptoms of the targeted disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of Parkinson's disease and related disorders, improving patient outcomes.
How similar studies have performed: While the approach of using multi-omics analyses for biomarker detection is innovative, similar studies have shown promise in identifying biomarkers for neurodegenerative diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PD (Postuma et al., 2015), MSA (Palma et al., 2018), DLB (McKeith et al., 2017), OND including acquired and hereditary ataxic syndrome with known etiology, progressive supranuclear palsy, corticobasal degeneration, and motor neuron disease. Exclusion Criteria: * na
Where this trial is running
Sesto Fiorentino, FI and 2 other locations
- Consorzio Interuniversitario Risonanze Magnetiche Metallo Proteine (CIRMMP) — Sesto Fiorentino, Fi, Italy (Recruiting)
- IRCCS Centro San Giovanni di Dio — Brescia, Italy (Recruiting)
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Fabio Moda, PHD — Fondazione IRCCS Istituto Neurologico Carlo Besta
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.