Detect neck norepinephrine nerve loss
- Trial ID
- NCT05741151
- Official Title
- Evaluation of Peripheral Catecholaminergic System in Neurodegenerative Diseases of the Central Nervous System. A Pilot Study.
- Goal
- Detect neck norepinephrine nerve loss
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study Type
- INTERVENTIONAL
- Enrollment
- 18 participants
- Conditions
- Parkinson Disease
- Interventions
- PET-Neck Parkinsonian patients
Summary For Families
The team wants to find out whether the peripheral catecholaminergic system in the neck, meaning the norepinephrine-producing nerve endings that reflect autonomic involvement, is damaged in people with Parkinson's, which could help with diagnosis and understanding how the disease spreads. Participants get a PET scan with a tracer that lights up catecholamine nerve terminals in the neck so clinicians can see loss or preservation of those fibers; the scan is diagnostic only and does not change medications or interact with levodopa. Enrollment is for adults 30 to 80 who meet Movement Disorder Society criteria for Parkinson's, excluding people with clear atypical features such as cerebellar signs, vertical gaze palsy, drug-induced parkinsonism, no response to high-dose levodopa, normal presynaptic dopamine imaging, parkinsonism limited to the legs for more than three years, or another diagnosis that better explains the symptoms.
Locations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying PET-Neck Parkinsonian patients. The team wants to find out whether the peripheral catecholaminergic system in the neck, meaning the norepinephrine-producing nerve endings that reflect autonomic involvement, is damaged in people with Parkinson's, which could help with diagnosis and understanding how the disease spreads. Participants get a PET scan with a tracer that lights up catecholamine nerve terminals in the neck so clinicians can see loss or preservation of those fibers; the scan is diagnostic only and does not change medications or interact with levodopa. Enrollment is for adults 30 to 80 who meet Movement Disorder Society criteria for Parkinson's, excluding people with clear atypical features such as cerebellar signs, vertical gaze palsy, drug-induced parkinsonism, no response to high-dose levodopa, normal presynaptic dopamine imaging, parkinsonism limited to the legs for more than three years, or another diagnosis that better explains the symptoms.
- Who can participate?
- Participants must be between 30 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 3 years.
- 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.