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This study is looking at a medicine called XBD173. We want to find out if it can improve blood flow in the brains of people living with Alzheimer’s disease.
XBD173 works by attaching to a protein called TSPO. TSPO is found in mitochondria, which are tiny parts of our cells that help produce energy. By attaching to TSPO, XBD173 may help the small blood vessels in the brain work better. Better blood flow may help keep the brain healthy and protect it from damage.
If you take part, you will be asked to take XBD173 capsules by mouth. Most participants will take one capsule twice a day for 4 weeks. During another part of the study, participants will take a placebo, which looks the same as XBD173 but does not contain any active medicine.
Most participants will:
- Take either XBD173 or placebo for 4 weeks
- Have a 6-week break
- Then take the other treatment for 4 weeks
Neither you nor the study team will know which treatment you are taking at the time. Find more information about why studies use blinding, randomisation and placebo controls.
Before joining the study, you will attend a screening visit to check whether the study is suitable for you.
During the study, participants will attend 4 main study visits and 2 shorter safety visits. At the main visits, you will have:
- Simple tests of memory and thinking
- A blood sample taken
- An MRI scan of the brain
An MRI scan uses a strong magnet to produce detailed pictures of the brain. It does not use X-rays. Some MRI scans will use a small amount of contrast dye to help show the brain’s blood vessels more clearly. During one MRI scan, you will be asked to breathe air containing a small amount of extra carbon dioxide for a few minutes. This is a safe way to measure how well the brain’s blood vessels respond to changes in blood flow.
The main part of the study lasts about 14 weeks.
XBD173 may not provide a direct benefit to you. However, the information collected may help researchers learn more about Alzheimer’s disease and develop treatments for people in the future. XBD173 has been used safely in previous studies.
We are also inviting healthy volunteers to take part. Healthy volunteers will attend for one MRI scan only and will not receive any study medication. Their results will help researchers compare brain blood flow between people with and without Alzheimer’s disease.
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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?
The purpose of this study is to find out whether treatment with VHB937 is safe and beneficial in people with early Alzheimer's disease. The study will evaluate the safety of VHB937, as well as its effects on memory and other thinking abilities, on daily activities, and on changes in the brain. The study will also observe and measure how VHB937 is processed by the body and how the body responds to it.
The aim of this study is to compare the study medicine VHB937 with a placebo (a treatment with no active medicine) to see:
- How VHB937 affects memory, other thinking abilities, daily activities and changes in the brain in people with Early Alzheimer’s Disease
- How safe VHB937 is in people who have early signs of Alzheimer’s disease.
How the study is carried out
This study is a double-blind placebo-controlled trial. This means participants will be selected at random to receive one of the following options:
- An intravenous infusion of VHB937 (low dose)
- An intravenous infusion of VHB937 (high dose)
- An intravenous infusion of Placebo (a 'dummy' treatment, which is an inactive substance with no active therapeutic effect that looks the same as the study drug).
Neither the participant, their study doctor, nor the study team will know who is getting the investigational treatment or placebo. This helps make the results fair.
After the double-blind part of the study participants will be offered the chance to join an extension phase, where they can continue receiving VHB937 in an open label format (meaning everyone receives the real drug, with no placebo). Your study doctor would discuss this with you.
Find more information about why studies use blinding, randomisation and placebo controls.
How is the drug given?
VHB937 or placebo is given by intravenous (IV) infusion, which is a drip into a vein in the arm.
Is the drug already approved for other illnesses?
No, VHB937 is not currently used or sold for any medical condition.
How long does treatment last?
The double-blind part of the study is 72 weeks long (about 1.5 years), followed by an optional open label extension.
What will participants need to do?
During the study, participants will:
- Take tests which check:
- Memory
- Thinking skills (cognition)
- Function
- Daily activities
- Behaviour
- Have positron emission tomography (PET) scans, which take pictures of the brain to check for changes linked to Alzheimer’s disease.
- Have lab tests and checkups which will include:
- blood tests and other lab tests
- neurological exams which help doctors look for any new side effects, such as symptoms or health changes that might happen after receiving the study drug.
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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.