Detect serotonin loss in Parkinson
- Trial ID
- NCT05516732
- Official Title
- Evaluation of Serotonergic Neurotransmission in Premotor and Motor Parkinson's Disease.
- Goal
- Detect serotonin loss in Parkinson
- Status
- RECRUITING
- Sponsor
- University of Exeter
- Study Type
- OBSERVATIONAL
- Enrollment
- 42 participants
- Conditions
- Parkinson Disease, Parkinson's, Parkinson's Disease, Neurodegenerative Diseases, Neurodegeneration, Positron Emission Tomography
- Interventions
- Positron Emission Tomography (PET) scan using CIMBI-36 tracer, Magnetic Resonance Imaging (MRI) Scan, Positron Emission Tomography (PET) scan using DASB tracer, FP-CIT Single-photon Emission Computed Tomography (SPECT) scan, Lumbar puncture
Summary For Families
Trying to map how serotonin signalling changes before and after Parkinson's motor symptoms, and how those changes relate to dopamine loss and clinical features. The team uses PET with DASB to measure serotonin transporter availability and PET with CIMBI-36 to image 5-HT2A receptor binding, plus FP-CIT SPECT to measure dopamine transporter loss, MRI for anatomy, and lumbar puncture to collect CSF biomarkers. There is no experimental drug; the protocol is observational, but people on serotonin-active drugs like SSRIs are excluded and PD medications must be stable with no recent changes. Adults aged 25 to 85 who can tolerate PET and MRI scans and a lumbar puncture, who are not pregnant and who have not had PD surgery or are on advanced pump or apomorphine therapy, are being recruited.
Locations
- University Of Exeter, Exeter, Devon, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Positron Emission Tomography (PET) scan using CIMBI-36 tracer. Trying to map how serotonin signalling changes before and after Parkinson's motor symptoms, and how those changes relate to dopamine loss and clinical features. The team uses PET with DASB to measure serotonin transporter availability and PET with CIMBI-36 to image 5-HT2A receptor binding, plus FP-CIT SPECT to measure dopamine transporter loss, MRI for anatomy, and lumbar puncture to collect CSF biomarkers. There is no experimental drug; the protocol is observational, but people on serotonin-active drugs like SSRIs are excluded and PD medications must be stable with no recent changes. Adults aged 25 to 85 who can tolerate PET and MRI scans and a lumbar puncture, who are not pregnant and who have not had PD surgery or are on advanced pump or apomorphine therapy, are being recruited.
- Who can participate?
- Participants must be between 25 Years and 85 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 4 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.