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

Recruiting now

Conditions studied: Parkinson Disease, MSA - Multiple System Atrophy, Lewy Body Dementia (LBD), Neurodegenerative Disease, Healthy Subjects (HS)

In brief

Clinical diagnosis of Parkinson's disease (PD), multiple system atrophy (MSA) and dementia with Lewy bodies (DLB) is challenging, especially in the early stages. Each disease is associated with distinct conformers of misfolded alpha-synuclein (maS) which form typical protein aggregates in the brain and represent key disease biomarkers. Thus, detection and characterization of intracerebral maS aggregates allow a definite diagnosis. The recent development of ultrasensitive assays enabled the detection of maS and other potential new biomarkers in peripheral tissues, although with several limitations. Here, the investigators propose to combine the expertise of leading and young researchers in the field of neurology, structural and molecular biology, biophysics and machine learning to perform ultrasensitive and multi-omics analyses of olfactory mucosa (OM), blood and urine of PD, MSA and DLB patients for detecting and characterizing key peripheral biomarkers allowing accurate disease recognition.

Key facts

Study ID

NCT06846658

Run by

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

People needed

180

Starts

2023-10-03

Expected to finish

2026-04-01

Last updated by the study team

2026-03-30

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• na

Where it is running

• Consorzio Interuniversitario Risonanze Magnetiche Metallo Proteine (CIRMMP) — Sesto Fiorentino, FI, Italy (enrolling)
• IRCCS Centro San Giovanni di Dio — Brescia, Italy (enrolling)
• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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