Differentiate neurodegenerative diseases using saliva
- Trial ID
- NCT06869135
- Official Title
- Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling
- Goal
- Differentiate neurodegenerative diseases using saliva
- Status
- RECRUITING
- Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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 goal is to find saliva-based biochemical markers that can help diagnose and distinguish Parkinson's, Alzheimer's, atypical parkinsonism, mild cognitive impairment, and even prodromal Parkinson's, so diagnosis could become easier and less invasive. The approach collects saliva samples over time and uses biochemical profiling to look for proteins, metabolites, or other molecules that reflect brain changes, offering a painless, repeatable way to complement or reduce the need for spinal fluid or imaging tests. They are enrolling adults 45 and older with diagnoses by standard criteria for PD, AD, atypical parkinsonism, prodromal PD, or MCI, who can consent and do not have active oral, infectious, oncological, or other systemic inflammatory diseases; PD participants should be on stable medication and not have vascular or drug-induced parkinsonism.
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 goal is to find saliva-based biochemical markers that can help diagnose and distinguish Parkinson's, Alzheimer's, atypical parkinsonism, mild cognitive impairment, and even prodromal Parkinson's, so diagnosis could become easier and less invasive. The approach collects saliva samples over time and uses biochemical profiling to look for proteins, metabolites, or other molecules that reflect brain changes, offering a painless, repeatable way to complement or reduce the need for spinal fluid or imaging tests. They are enrolling adults 45 and older with diagnoses by standard criteria for PD, AD, atypical parkinsonism, prodromal PD, or MCI, who can consent and do not have active oral, infectious, oncological, or other systemic inflammatory diseases; PD participants should be on stable medication and not have vascular or drug-induced parkinsonism.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 1 month.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.