Positron Emission Tomography (PET)… for Parkinson's (NCT05516732)
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?
- 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 4 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?
- 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); PET scan (minimally invasive); Blood draw (minimally invasive); Injection (minimally invasive); MRI scan (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.