Positron Emission Tomography (PET)… for Parkinson's (NCT05516719)

Find brain marker showing 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
Find brain marker showing 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 are trying to find a measurable brain marker that shows the presence or progression of Parkinson's disease, to improve our understanding of brain changes and help develop treatments that slow symptom worsening. Participants have detailed imaging: positron emission tomography (PET) using a tracer called BU99008 that highlights astroglia cells (a type of brain support cell), single photon emission computed tomography (SPECT) with FP-CIT, and magnetic resonance imaging (MRI); PET and SPECT use small amounts of radiation and tracers, MRI uses magnetic fields. Visits take place in London at Hammersmith Hospital and a nearby imaging center, with two sets of visits 12 months apart that include screening, the MRI and PET, a SPECT scan, and an optional lumbar puncture to collect spinal fluid; there can be up to eight visits in total, with two lumbar punctures optional. Adults 25 or older who can give informed consent and travel to the sites can apply, but people with dementia, certain medical problems or implants that prevent MRI, pregnancy or breastfeeding, or who are taking medications that interfere with the scans or the tracer will not be eligible, and participants must follow the study's contraception rules.

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 are trying to find a measurable brain marker that shows the presence or progression of Parkinson's disease, to improve our understanding of brain changes and help develop treatments that slow symptom worsening. Participants have detailed imaging: positron emission tomography (PET) using a tracer called BU99008 that highlights astroglia cells (a type of brain support cell), single photon emission computed tomography (SPECT) with FP-CIT, and magnetic resonance imaging (MRI); PET and SPECT use small amounts of radiation and tracers, MRI uses magnetic fields. Visits take place in London at Hammersmith Hospital and a nearby imaging center, with two sets of visits 12 months apart that include screening, the MRI and PET, a SPECT scan, and an optional lumbar puncture to collect spinal fluid; there can be up to eight visits in total, with two lumbar punctures optional. Adults 25 or older who can give informed consent and travel to the sites can apply, but people with dementia, certain medical problems or implants that prevent MRI, pregnancy or breastfeeding, or who are taking medications that interfere with the scans or the tracer will not be eligible, and participants must follow the study's contraception rules.
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?
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 and 8 months.
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.
How many visits does this trial involve?
Up to 8 in-person visits, arranged in two sets spaced 12 months apart; two of the visits (lumbar punctures) are optional.
What procedures are involved in this trial?
Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); PET scan (minimally invasive); MRI scan (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov