Brain scans track Parkinson progression
- Trial ID
- NCT05516719
- Official Title
- Longitudinal Investigation of Imidazoline-2 Binding Site as a Novel Marker of Disease Progression in Parkinson's Disease: An [11C]BU99008 PET Study
- Goal
- Brain scans track Parkinson progression
- Status
- RECRUITING
- Sponsor
- University of Exeter
- Study Type
- OBSERVATIONAL
- Enrollment
- 44 participants
- Conditions
- Parkinson's, Parkinson Disease, Parkinson's Disease, Neurodegenerative Diseases, Neurodegeneration, Positron Emission Tomography
- Interventions
- Positron Emission Tomography (PET) scan using BU99008 tracer, FP-CIT Single-photon Emission Computed Tomography (SPECT) scan, Magnetic Resonance Imaging (MRI) Scan, Lumbar puncture
Summary For Families
They're testing whether imaging a brain protein called the imidazoline-2 binding site can track Parkinson's progression over time, so we might have a reliable biomarker of disease stage and change. Participants get PET scans with the [11C]BU99008 tracer that binds to I2BS so the images show where and how much of that target is present in the brain. They also have dopamine transporter SPECT, MRI, and lumbar puncture so researchers can compare I2BS signal with dopamine loss and CSF biomarkers, and the tracer is for imaging only so it does not treat Parkinson's or interact with levodopa, though some drugs that affect I2BS or DaT imaging must be paused before scans. The study is looking for adults 25 and older with Parkinson's who can consent and tolerate scans and lumbar puncture, and it excludes people with dementia, certain medications or bleeding risks, or other conditions that make MRI or lumbar puncture unsafe.
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 BU99008 tracer. They're testing whether imaging a brain protein called the imidazoline-2 binding site can track Parkinson's progression over time, so we might have a reliable biomarker of disease stage and change. Participants get PET scans with the [11C]BU99008 tracer that binds to I2BS so the images show where and how much of that target is present in the brain. They also have dopamine transporter SPECT, MRI, and lumbar puncture so researchers can compare I2BS signal with dopamine loss and CSF biomarkers, and the tracer is for imaging only so it does not treat Parkinson's or interact with levodopa, though some drugs that affect I2BS or DaT imaging must be paused before scans. The study is looking for adults 25 and older with Parkinson's who can consent and tolerate scans and lumbar puncture, and it excludes people with dementia, certain medications or bleeding risks, or other conditions that make MRI or lumbar puncture unsafe.
- Who can participate?
- Participants must be at least 25 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 and 8 months.
- 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.