Dementia Support Line
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What is the goal of this study?
This study is looking at a new gene therapy called AVB 101. It is being developed to treat people with Frontotemporal Dementia who carry a Progranulin Mutation (FTD GRN).
FTD GRN is a rare type of dementia that usually starts earlier in life. It affects behaviour, language, and movement. People with this condition have very low levels of a protein called progranulin (PGRN) in the brain. Without enough PGRN, brain cells (neurons) begin to die, and the brain cannot work properly.
AVB 101 is designed to help the body make more PGRN, which may help protect brain cells.
What is the study trying to find out?
The study has three main questions:
- Is a one time dose of AVB 101 safe for people with FTD GRN?
- Does AVB 101 increase PGRN levels in the brain back to normal or close to normal?
- Can AVB 101 help slow down or stop the worsening of FTD GRN?
What treatment will participants receive?
This study does not use a placebo. This means everyone who joins the study will receive AVB 101.
AVB 101 is a gene therapy which is given once, directly into the brain, using a special medical procedure. After this one time treatment, participants will have regular check-ups at the study centre for 5 years so doctors can see how they are doing and how well the treatment is working.
Trial recruitment and assessment sites are in London and Cambridge. However, all participants will be required to travel to the trial surgical site in Cardiff to receive AVB-101.
What will participants be asked to do during the study?
During the study, participants will:
- Have some laboratory tests, such as blood tests. These tests help doctors check for any new side effects, such as symptoms or health changes that might happen after receiving the study medicine.
- Have brain scans called MRI scans. These scans take detailed pictures of the brain to help doctors check brain health and safety.
- Complete tests that look at memory, thinking, and emotional wellbeing.
If participants would like more details about the tests, procedures, or number of visits, the study team can provide full information.
It is a one-time treatment of AVB-101 with follow-up assessments for 5 years.
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What is the aim of the study?
This study is testing a new medicine called ALN 5288 for people with Alzheimer’s disease. ALN 5288 is a treatment that helps the body make less of a protein called tau. Too much tau in the brain can cause it to clump together, which may lead to memory and thinking problems.
The medicine works by finding and breaking down the instructions inside cells that tell the body to make tau. By reducing tau production, the aim is to lower tau levels, and so slow down the changes in the brain caused by Alzheimer’s disease. The medicine is given as an injection into the space around the spine so it can reach the brain more directly.
What the study wants to find out
The study has two main goals:
- To check if ALN 5288 is safe for people with Alzheimer’s disease and to see how well people can tolerate it.
- To learn how the medicine works inside the body, including what it does and how the body uses and clears it after it is given.
How the study is carried out
This study is a double-blind placebo-controlled trial. This means:
- Some people will get ALN 5288.
- Some people will get a placebo (a dummy treatment that has no medicine in it).
Neither the participant, their study doctor, nor the study team will know who is getting which treatment during the first part of the study. This helps make the results fair.
In the second part of the study, everyone will get ALN 5288, no matter what they received at the start. This part is called an open label extension, because everyone and their doctors will know they are getting the real medicine.
Find more information about why studies use blinding, randomisation and placebo controls.
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What is the aim of the study?
Dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD) are related complex illnesses with a wide range of distressing symptoms. People with DLB/PDD have worse quality of life, more complex symptoms, higher care costs, and are more sensitive to medications than people with Alzheimer’s disease.
Acetylcholinesterase Inhibitors (AChEI) are commonly used medicines that can help people with DLB/PDD by improving day to day functioning and thinking abilities. Another drug which might help is memantine, used to treat moderate to severe confusion in Alzheimer’s disease. It may help to improve memory, awareness and the ability to perform daily functions. However, it is not clear if adding memantine to AChEI is beneficial for people with DLB/PDD.
The aim of this trial is to find out if adding memantine to AChEI improves overall health and functioning for people with Dementia with Lewy bodies or Parkinson’s disease dementia.
What will participants be asked to do during the study?
Participants will need to have a relative or carer willing to support the participant’s participation in the study and who is able to answer questions about the participant’s condition.
People in the study will be randomly assigned, like flipping a coin, to receive either memantine or a placebo/dummy medication. The medication will be in the form of tablets taken once a day.
Find more information about why studies use randomisation and placebo controls.
During the study, participants will be asked to:
- take their allocated medication once a day as prescribed by the study doctor.
- complete a range of assessments and questionnaires about their health at both the start (baseline) and 26 weeks. These assessments may take 2-3 hours to complete. Breaks can be taken during the visit, including extended breaks of up to 7 days
- provide regular updates about their health while taking part in the study.
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What is the aim of the study?
Alzheimer's disease (AD) is a type of dementia that affects memory, thinking and behaviour. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks.
It is believed that changes in two proteins in the brain, beta-amyloid and tau, cause AD. Plaques (clumps of beta-amyloid) and tangles (twisted threads of tau) are the main reasons that brain cells are damaged. These two proteins are the focus of many researchers working on treatments that could help slow down or stop AD.
This study is testing a new medicine called trontinemab. It is designed to help remove amyloid plaques from the brain, which may help slow down early symptoms of Alzheimer’s disease.
Trontinemab is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved trontinemab for the treatment of AD.
The aim of this study is to compare trontinemab with a placebo (a dummy medicine) to see: how well it works, and how safe it is in people who have early signs of Alzheimer’s disease.
Participants will be randomly assigned (50/50 chance) to receive either: Trontinemab, or a placebo (a treatment with no active medicine).
Trontinemab or placebo is given by intravenous (IV) infusion, which is a drip into a vein in the arm. The first infusion takes about 4 hours. If it is well tolerated, future infusions may be shortened to about 2 hours.
How long the study lasts
The total treatment period lasts 72 weeks (approx. 18 months) and is divided into two phases:
- Induction Phase (first 6 months): participants will receive an infusion every 4 weeks (Weeks 0, 4, 8, 12, 16, 20, and 24)
- Maintenance Phase (after 6 months): participants will switch to receiving an infusion every 12 weeks (Weeks 36, 48, and 60) until the end of the study.
Brain Scans (Imaging)
Participants will have a number of brain scans to check brain health and to measure amyloid and tau throughout the study.
Magnetic resonance imaging (MRI)
- Shows the structure of the brain:
- Helps check for safety changes, like swelling or tiny bleeds (called ARIA).
- When: screening, Weeks 4, 12, 24, 48, and 72.
Positron emission tomography (PET) scans
Amyloid PET scan
- Uses a small amount of a radioactive tracer to measure amyloid plaques in the brain.
- When: screening, one mid study scan (Week 12 or Week 28), and Week 72.
Tau PET scan (optional)
- Measures tau tangles in the brain.
- Participants can choose whether to take part.
- When: Baseline and Week 72.
Total time of participation in the study will be about 1 year and 7 months. Participants have the right to stop study treatment and leave the study at any time, if they wish to do so. After this study ends, participants, if eligible, will be offered the option to join an open label extension study where everyone will receive trontinemab.
Find more information about why studies use blinding, randomisation and placebo controls.
Age range
Recruitment end
Disease type
Trial locations
What is the aim of the study?
Alzheimer's disease (AD) is a type of dementia that affects memory, thinking and behaviour. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks.
It is believed that changes in two proteins in the brain, beta-amyloid and tau, cause AD. Plaques (clumps of beta-amyloid) and tangles (twisted threads of tau) are the main reasons that brain cells are damaged. These two proteins are the focus of many researchers working on treatments that could help slow down or stop AD.
This study is testing a new medicine called trontinemab. It is designed to help remove amyloid plaques from the brain, which may help slow down early symptoms of Alzheimer’s disease.
Trontinemab is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved trontinemab for the treatment of AD.
The aim of this study is to compare trontinemab with a placebo (a dummy medicine) to see:
- How well it works
- How safe it is in people who have early signs of Alzheimer’s disease.
Participants will be randomly assigned (50/50 chance) to receive either:
- Trontinemab, or
- A placebo (a treatment with no active medicine)
Trontinemab or placebo is given by intravenous (IV) infusion, which is a drip into a vein in the arm. The first infusion takes about 4 hours. If it is well tolerated, future infusions may be shortened to about 2 hours.
Find more information about why studies use blinding, randomisation and placebo controls.
How long the study lasts
Total time of participation in the study will be about 1 year and 7 months. Participants have the right to stop study treatment and leave the study at any time, if they wish to do so. After this study ends, participants, if eligible, will be offered the option to join an open label extension study where everyone will receive trontinemab.
The total treatment period lasts 72 weeks (approx. 18 months) and is divided into two phases:
- Induction Phase (first 6 months): participants will receive an infusion every 4 weeks (Weeks 0, 4, 8, 12, 16, 20, and 24)
- Maintenance Phase (after 6 months): participants will switch to receiving an infusion every 12 weeks (Weeks 36, 48, and 60) until the end of the study.
Brain Scans (Imaging)
Participants will have a number of brain scans to check brain health and to measure amyloid and tau throughout the study:
Magnetic resonance imaging (MRI)
- Shows the structure of the brain.
- Helps check for safety changes, like swelling or tiny bleeds (called ARIA).
- When: screening, Weeks 4, 12, 24, 48, and 72.
Positron emission tomography (PET) scans
Amyloid PET scan
- Uses a small amount of a radioactive tracer to measure amyloid plaques in the brain.
- When: screening, one mid study scan (Week 12 or Week 28), and Week 72.
Tau PET scan (optional)
- Measures tau tangles in the brain.
- Participants can choose whether to take part.
- When: Baseline and Week 72.