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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

Study acronym: EXTRAORDINARY
StatusActive, Not Recruiting
PhaseNot specified
Started2023-10-03
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-08-29
notable
Enrollment closed, study ongoing
2026-08-29
critical
Primary completion pushed: 2026-04 → 2027-04
2026-08-29
minor
Completion pushed: 2026-04 → 2027-04
Trial Details
NCT Number NCT06846658
Lead Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Conditions Parkinson Disease, MSA - Multiple System Atrophy, Lewy Body Dementia (LBD), Neurodegenerative Disease, Healthy Subjects (HS)
Enrollment 180 participants
Start Date 2023-10-03
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-28