PET-Neck Parkinsonian patients for Parkinson's (NCT05741151)
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?
- 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 3 years.
- 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- There are 4 study visits (visit 1 through visit 4); the neurological evaluation will be performed a maximum of three months after the imaging examinations.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Injection (minimally invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.