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RecruitingTherapeutic exploratory (Phase II)Interventional

Synaptic density and tau pathology in Alzheimer’s disease (SYNAPSE)

Alzheimer's disease damages the brain by causing vital connections between nerve cells to break down, while harmful proteins like tau build up. The SYNAPSE study uses advanced imaging called PET scans to look closely at these two changes together. Participants will receive small amounts of two imaging dyes, known as tracers, which light up on scans to show brain connections and tau proteins. Researchers want to find out where in the brain these changes happen and how closely they are linked. This is an observational imaging study rather than a trial of a new cure. Even so, it could play a crucial role in improving how doctors diagnose Alzheimer's in the future and could help scientists design better, more targeted treatments. The study is open to adults aged 18 and older.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Amsterdam UMC Stichting
Enrolment target
30
Start
10 Dec 2024

What is this study about?

Our brains rely on billions of tiny connections between nerve cells, called synapses, to share messages, store memories, and help us think. In Alzheimer's disease, these vital connections slowly fade away. At the same time, an abnormal protein called tau builds up inside brain cells, forming tangles that disrupt normal brain function. Doctors know both of these problems happen, but they want to learn much more about how they affect each other.

The SYNAPSE study uses modern scanning technology to see both tau proteins and nerve connections in the brain at the same time. Researchers will use two special imaging dyes called 18F-Synvest-1 and Flortaucipir. When injected in tiny amounts, these dyes attach to specific targets in the brain and glow on a PET scanner. This allows researchers to measure where connections are being lost and where tau is gathering.

By comparing these images, researchers hope to map the relationship between tau build-up and the loss of brain connections. Understanding which areas of the brain are damaged first can help researchers unlock the secrets of how Alzheimer's progresses. Although taking part will not cure memory loss, the findings could help doctors spot Alzheimer's earlier and test new treatments more accurately in the future.

Key takeaways

  • The SYNAPSE study investigates how Alzheimer's disease damages brain connections.
  • It uses advanced PET scans to look at both nerve connections and tau proteins together.
  • This is an observational imaging study, not a test of a new drug or cure.
  • Taking part involves clinic visits, health checks, and brain scans using safe imaging dyes.
  • Your regular NHS medical care will continue unaffected whether you choose to take part or not.

Who may be eligible?

This study is open to adults of any gender who are 18 years old or older. It is designed to include people living with Alzheimer's disease to help researchers see how the condition changes the brain.

While the study accepts a wide adult age range, you will need to meet specific health criteria to make sure the scans are safe for you. For instance, people who cannot have brain scans or who have certain other serious brain conditions may not be able to take part.

The research team will review your medical history and current health before you join to ensure taking part is both safe and suitable for your individual circumstances.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I have been diagnosed with Alzheimer's disease or memory difficulties.
  3. I am comfortable having an injection in my arm for the scan dye.
  4. I am able to lie still on a scanner bed for up to an hour.
  5. I am interested in taking part in brain imaging research.
Answer every question to see your result.

What does participation involve?

Taking part in this study involves hospital visits for detailed health checks and brain imaging. You will have PET scans, which involve lying still on a padded bed while a ring-shaped scanner takes pictures of your brain. Before each scan, a specialist will give you an injection of a small, safe amount of an imaging dye into a vein in your arm.

You will have scans to measure both your brain connections and the tau protein. The study team will carry out health checks, such as monitoring your blood pressure and checking how you feel throughout the appointment. There are no ongoing medications to take at home, and the visits are spaced out according to the study plan. The study team will clearly explain the full schedule and how many hours you will need to spend at the clinic.

Potential risks and benefits

Taking part will not directly treat or cure your memory symptoms, but you will be helping to advance vital dementia research for the future. The scans carry a small amount of radiation from the imaging dyes, similar to standard medical X-rays or routine scans. You might also feel a slight pinch or get a small bruise where the dye is injected. The research team will monitor you closely to keep you comfortable. You are free to leave the study at any time, and doing so will not affect your normal NHS care or medical treatment in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Netherlands

Common questions

Will taking part improve my memory?

No, this study is designed to help researchers understand the brain better through scans. It does not provide a new treatment or medication to improve memory.

Are the brain scans painful?

The scans themselves are completely painless. You will only feel a quick scratch when the imaging dye is injected into a vein in your arm.

How long do the PET scans take?

A scan usually takes between 30 and 60 minutes, during which you will need to lie still on a comfortable bed.

Is the radiation from the scans dangerous?

The amount of radiation used is very small and kept within strict safety limits set by UK medical regulators.

Can I bring a family member or carer with me?

Yes, study teams welcome family members or carers to support you during your clinic appointments.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Synaptic density and tau pathology in Alzheimer’s disease (S…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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