A PET study to assess brain α-synuclein deposition using [11C] MK-7337
Research type
Research Study
Full title
An open-label study to evaluate brain α-synuclein deposition using Positron Emission Tomography (PET) and [11C]MK-7337
IRAS ID
334626
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Invicro
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
"Research Summary"
Parkinson’s disease (PD) has a significant impact on quality of life and increased mortality. A protein called alpha-synuclein (ASYN) is strongly implicated in PD, but currently we do not have a reliable way to detect this protein and which brain areas are affected by it, apart from at post-mortem. Positron emission tomography (PET) is a non-invasive imaging technique that can quantify the concentration of particular molecules using radioactively tagged probes called radiotracers, (when a viable tracer exists). This study will analyse deposition of ASYN using a novel PET tracer called [11C]MK-7337 in people with PD and compare this to the brains of people with Alzheimer’s disease (AD) and healthy elderly participants who do not have PD or AD.Male and female participants aged 55-80 will have a screening visit, a baseline imaging visit involving a PET scan and MRI and some subjects will have a follow-up imaging visit involving a further PET scan. The study will take part at 1 imaging centre.
"Summary of Results"
Parkinson’s disease is a brain condition that affects movement. It is linked to a build-up of a protein called α-synuclein in the brain. In this study, researchers tested a new imaging dye (called [11C]MK-7337) used with Positron Emission Tomography (PET) scans. The goal was to see if the dye could safely enter the brain and highlight this protein in people with Parkinson’s disease compared to healthy volunteers.Who Took Part
A total of 12 adults completed the study: 8 people with Parkinson’s disease and 4 healthy older volunteers.
What Was Done
All participants had a Magnetic Resonance Imaging (MRI) scan to picture their brain structure and a PET scan with the [11C]MK-7337 dye. Three participants with Parkinson’s disease had a second PET scan using a different dye ([18F]MK-6240). This second scan checked for a different protein (tau) to ensure the main dye was only attaching to α-synuclein. Researchers checked on all participants by phone a week after their scans.
Key Findings
The [11C]MK-7337 dye safely entered the brain, showing higher uptake levels in brain regions key to Parkinson’s disease in affected participants compared to healthy volunteers. The secondary PET scans confirmed no significant binding to tau protein, proving that [11C]MK-7337 specifically targets α-synuclein. Overall, the dye demonstrated a good safety profile with no tracer-related side effects, no serious safety issues, and a 100% completion rate among enrolled participants. Two participants experienced mild cold or flu-like symptoms, but these were unrelated to the study procedures and resolved quickly.
Conclusion
The study showed that [11C]MK-7337 PET scans are a safe and effective way to detect α-synuclein protein build-up in the brain. This tool could help researchers measure Parkinson’s disease and test future treatments.
REC name
Wales REC 7
REC reference
23/WA/0306
Date of REC Opinion
22 Nov 2023
REC opinion
Further Information Favourable Opinion