Saliva collection, longitudinal for Parkinson's (NCT06869135)
Saliva test detects Parkinson earlier
- Trial ID
- NCT06869135
- Official Title
- Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling
- Goal
- Saliva test detects Parkinson earlier
- Status
- RECRUITING
- Sponsor
- Fondazione Don Carlo Gnocchi ETS
- Study Type
- OBSERVATIONAL
- Enrollment
- 242 participants
- Conditions
- Neurodegenerative Diseases, Parkinson Disease, Alzheimer Disease, Parkinsonism, Mild Cognitive Impairment (MCI), Prodromal Parkinson's Disease
- Interventions
- Saliva collection, longitudinal
Summary For Families
The study is testing whether a quick, inexpensive saliva test can spot neurodegenerative diseases early, tell Parkinson's disease apart from similar disorders and Alzheimer's, and track changes over time so care can be better personalized. Researchers will collect saliva at the start and after 12 months, pull out tiny particles from the saliva called saliva-derived extracellular vesicles, and use Raman spectroscopy to create a biochemical "fingerprint" without staining; they will also measure known protein markers such as alpha-synuclein for Parkinson's, amyloid-beta 1-42 for Alzheimer's and mild cognitive impairment, and neurofilament light chain as a general marker of nerve damage. The study is enrolling people aged 45 and older with Parkinson's disease, atypical parkinsonism, early or prodromal Parkinson's, Alzheimer's disease, or mild cognitive impairment who can give consent, do not have chronic mouth inflammation or other serious or infectious conditions, and, for the Parkinson's group, are on stable medication and do not have vascular, familial, drug-induced parkinsonism, clear signs of atypical parkinsonism, or severe dementia (very low score on the Montreal Cognitive Assessment).
Locations
- IRCCS Don Gnocchi, Fondazione Don Gnocchi, Florence, FI, Italy
- Azienda Ospedaliero Universitaria Careggi Firenze, Florence, Italy
- IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS, Milan, Italy
- IRCCS Istituto Neurologico "Carlo Besta", Milan, Italy
- Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus, Parma, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Saliva collection, longitudinal. The study is testing whether a quick, inexpensive saliva test can spot neurodegenerative diseases early, tell Parkinson's disease apart from similar disorders and Alzheimer's, and track changes over time so care can be better personalized. Researchers will collect saliva at the start and after 12 months, pull out tiny particles from the saliva called saliva-derived extracellular vesicles, and use Raman spectroscopy to create a biochemical "fingerprint" without staining; they will also measure known protein markers such as alpha-synuclein for Parkinson's, amyloid-beta 1-42 for Alzheimer's and mild cognitive impairment, and neurofilament light chain as a general marker of nerve damage. The study is enrolling people aged 45 and older with Parkinson's disease, atypical parkinsonism, early or prodromal Parkinson's, Alzheimer's disease, or mild cognitive impairment who can give consent, do not have chronic mouth inflammation or other serious or infectious conditions, and, for the Parkinson's group, are on stable medication and do not have vascular, familial, drug-induced parkinsonism, clear signs of atypical parkinsonism, or severe dementia (very low score on the Montreal Cognitive Assessment).
- Who can participate?
- Participants must be at least 45 Years.
- Where is this trial located?
- This trial is recruiting at 5 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 1 month.
- 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.
- How many visits does this trial involve?
- Saliva will be collected at recruitment (T0) and again after 12 months (T12).