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NCT06846658Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 28 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
180 (estimated)
First submitted
11 Feb 2025
Start date
3 Oct 2023
Primary completion date
Apr 2027
Lead sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
NCT number
NCT06846658

What you commit to

  • Study type: Observational
  • Planned participants: 180
  • From 3 Oct 2023 to the primary completion date, Apr 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • na

Who the study is looking for

  • 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.

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Centro San Giovanni di Dio
Coordinator of this site? Confirm its status
BresciaItalyUnknown status
Fondazione IRCCS Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Consorzio Interuniversitario Risonanze Magnetiche Metallo Proteine (CIRMMP)
Coordinator of this site? Confirm its status
Sesto FiorentinoItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.