An open-label, single-center study to evaluate the safety and test-retest characteristics of [11C]MODAG-005 as PET radioligand for imaging pathological alpha-synuclein deposition in the brains of patients with Parkinson’s disease (PD) or Multiple System Atrophy (MSA) compared to age-matched healthy controls (AMHC)
This research is trying out a new scan, called a PET scan, to look for a special protein called alpha-synuclein in the brain. In conditions like Parkinson's disease (PD) and Multiple System Atrophy (MSA), too much of this protein can build up. This study will give a small amount of a special tracer, called [11C]MODAG-005, which lights up during the scan to show where these proteins are. Researchers want to see if this new scan is safe and if it gives clear and reliable results. They will compare scans from people with PD and MSA to scans from healthy volunteers to learn more about how these conditions affect the brain. This could help in developing better ways to diagnose and treat these conditions in the future.
Em resumo
Sobre o que é este estudo?
This study is a very early step in understanding brain conditions like Parkinson's disease (PD) and Multiple System Atrophy (MSA). In these conditions, a protein called alpha-synuclein can collect in the brain in ways it shouldn't. Doctors believe this build-up plays a big part in causing the symptoms of these diseases. Right now, it's hard to clearly see these protein changes in living people, which makes it difficult to diagnose early or track how treatments are working.
Researchers are using a new technique called a PET scan. For this scan, a very tiny amount of a special substance called a 'tracer' (in this case, [11C]MODAG-005) is put into the body. This tracer is designed to attach to the alpha-synuclein protein clumps, and then a special camera picks up signals from the tracer. This allows doctors to create detailed pictures that show where these protein clumps are located in the brain.
The main goals of this study are to make sure this new tracer is safe for people to use and to see if the PET scan results are consistent and clear. They'll be scanning people with Parkinson's, people with Multiple System Atrophy, and healthy volunteers. By comparing the scan results, researchers hope to learn more about these conditions and eventually develop better tools for diagnosing them earlier and testing new medicines.
Pontos principais
- New study to investigate imaging a specific brain protein.
- Aims to improve understanding of Parkinson's and Multiple System Atrophy.
- Uses a new PET scan 'tracer' called [11C]MODAG-005.
- First study in humans to check safety and scan reliability.
- Will compare people with Parkinson's, MSA, and healthy volunteers.
- Could help develop better ways to diagnose and treat these conditions in the future.
Quem pode ser elegível?
This study is looking for volunteers aged 18 and over. It's open to both men and women. They are specifically looking for people who have been diagnosed with Parkinson's disease, people who have Multiple System Atrophy, and also healthy adults who are about the same age.
It's important that you don't have any serious medical conditions that might make taking part unsafe. The research team will do some checks to make sure you're a good fit for the study and that it's safe for you to participate.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- Have you been diagnosed with Parkinson's disease or Multiple System Atrophy, or are you a healthy adult?
- Are you able to travel to the study centre?
- Are you able to lie still for a brain scan?
- Do you feel generally well enough to participate in a research study?
O que envolve a participação?
This is a 'first-in-human' study, meaning it's the first time this specific tracer is being given to people. Taking part would involve a visit to a special research facility. During your visit, you would have a PET scan, where a small amount of the tracer, [11C]MODAG-005, would be given to you. This is an open-label study, which means both you and the study team will know you are receiving the tracer. There will also be health checks and assessments to ensure your safety and monitor your body's response. The exact number of visits, duration of each visit, and overall length of your participation would be explained in full by the study team.
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Perguntas frequentes
What is alpha-synuclein?
It's a natural protein in the brain. In Parkinson's and Multiple System Atrophy, too much of it can build up, forming clumps that may harm brain cells.
O que é uma tomografia por emissão de pósitrons (PET)?
It's a special type of scan that uses a small amount of a 'tracer' to create detailed pictures of organs and tissues, like the brain, to see how they're working or if there are any unusual changes.
Is the tracer safe?
The tracer, [11C]MODAG-005, is new to humans, but it has been carefully tested before this study. Your safety will be the research team's top priority, and you'll be closely monitored throughout.
Will I get any medicine in this study?
No, this study is about using a scanning method, not testing a new medication. You will receive a very small amount of a 'tracer' to help with the scan.
What's the difference between this and a normal brain scan?
This PET scan is designed to specifically highlight microscopic protein clumps that normal scans, like an MRI or CT, usually cannot see in detail.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Discussão
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