Actively Recruiting
Exploring the Olfactory Mucosa, Blood and Urine for Early Biomarkers of Parkinson's Disease, Atypical Parkinsonisms and Lewy Body Dementia
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-03-30
180
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring early biomarkers in the olfactory mucosa, blood, and urine to improve diagnosis of Parkinson's disease (PD), multiple system atrophy (MSA), and dementia with Lewy bodies (DLB). These diseases are linked to misfolded alpha-synuclein proteins that form aggregates in the brain, which are key diagnostic markers. The study combines expertise in neurology, molecular biology, biophysics, and machine learning to analyze these biomarkers for better disease recognition. The study uses advanced and ultrasensitive tests such as RT-QuIC, Simoa SR-X, ELISA, and NTA on samples of olfactory mucosa, blood, and urine from patients with PD, MSA, and DLB. Techniques like transmission electron microscopy (TEM) and nuclear magnetic resonance (NMR) will characterize protein aggregates. Machine learning will combine clinical and experimental data to identify specific patterns that could distinguish these diseases. Participants will provide easily collectible samples like olfactory mucosa, blood, and urine periodically for up to three years. Researchers will assess olfactory function and analyze biomarkers to develop predictive models for diagnosis. The study includes safety monitoring and aims to enable ongoing disease monitoring and evaluation of treatment effects. The total study duration is three years, with multiple assessments and advanced laboratory analyses conducted over this period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's disease (PD), multiple system atrophy (MSA), dementia with Lewy bodies (DLB), or other related neurological disorders including ataxic syndromes, progressive supranuclear palsy, corticobasal degeneration, and motor neuron disease.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants provide olfactory mucosa, blood, and urine samples periodically for biomarker analysis and clinical assessments including olfactory function testing.
Periodic visits over 3 years for sample collection and assessments
Trial Site Locations
Total: 3 locations
1
Consorzio Interuniversitario Risonanze Magnetiche Metallo Proteine (CIRMMP)
Sesto Fiorentino, FI, Italy, 50019
Actively Recruiting
2
IRCCS Centro San Giovanni di Dio
Brescia, Italy, 25125
Actively Recruiting
3
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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