Parkinson's Trial NCT06846658
Distinguish Parkinsons from similar conditions
- Trial ID
- NCT06846658
- Official 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
- Goal
- Distinguish Parkinsons from similar conditions
- Status
- RECRUITING
- Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Study Type
- OBSERVATIONAL
- Enrollment
- 180 participants
- Conditions
- Parkinson Disease, MSA - Multiple System Atrophy, Lewy Body Dementia (LBD), Neurodegenerative Disease, Healthy Subjects (HS)
Summary For Families
Finding ways to tell Parkinson's disease, multiple system atrophy, and dementia with Lewy bodies apart early on, by looking for disease-specific markers in easy-to-get samples like the lining inside the nose that senses smell, blood, and urine. The team will use several ultrasensitive lab methods, including a test that amplifies and detects misfolded alpha-synuclein, a very high-sensitivity protein detector, standard protein tests, particle analysis, and imaging and structural techniques, then combine those results with smell testing, clinical information, statistics, and custom machine learning to look for distinct disease "fingerprints." About 180 people will be enrolled, including people diagnosed with Parkinson's, multiple system atrophy, dementia with Lewy bodies, other neurodegenerative disorders, and healthy volunteers; no specific age limits are listed.
Locations
- Consorzio Interuniversitario Risonanze Magnetiche Metallo Proteine (CIRMMP), Sesto Fiorentino, FI, Italy
- IRCCS Centro San Giovanni di Dio, Brescia, Italy
- Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. Finding ways to tell Parkinson's disease, multiple system atrophy, and dementia with Lewy bodies apart early on, by looking for disease-specific markers in easy-to-get samples like the lining inside the nose that senses smell, blood, and urine. The team will use several ultrasensitive lab methods, including a test that amplifies and detects misfolded alpha-synuclein, a very high-sensitivity protein detector, standard protein tests, particle analysis, and imaging and structural techniques, then combine those results with smell testing, clinical information, statistics, and custom machine learning to look for distinct disease "fingerprints." About 180 people will be enrolled, including people diagnosed with Parkinson's, multiple system atrophy, dementia with Lewy bodies, other neurodegenerative disorders, and healthy volunteers; no specific age limits are listed.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 3 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 6 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.