Exploring the Olfactory Mucosa, Blood and Urine for the Identification of Early Biomarkers of Par… (NCT06846658) | Clinical Trial Compass
RecruitingNot Applicable
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
Italy180 participantsStarted 2023-10-03
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is collecting samples from the olfactory mucosa, blood, and urine — can you explain what the nasal mucosa sampling actually involves, and whether there's any discomfort or risk I should know about before considering it?
2Since this study is focused on finding early biomarkers rather than testing a treatment, what would I actually gain from participating — would I receive any information about my own results, or is this purely to benefit future patients?
3The trial is also enrolling healthy subjects alongside people with Parkinson's, MSA, and Lewy body dementia — does my specific diagnosis or stage of disease affect whether participating might be appropriate for me to discuss with you?
4Because this is a biomarker discovery study and not a treatment trial, could you help me understand how joining this fits alongside my current care plan — and whether there's any reason it might interfere with my existing treatment or monitoring?
5If the researchers do identify a predictive model from this study, how might that eventually change how conditions like mine are diagnosed or caught earlier, and is there any way I'd be informed of those findings down the line?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identify a predictive model for the diagnosis of PD, MSA and DLB
Timeframe: 3 years
Trial details
NCT IDNCT06846658
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta