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.

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.

What is the aim of the study?

This study is testing a new investigational medicine called LY3954068 for people with Alzheimer’s disease.

LY3954068 is an investigational treatment that is intended to help the body make less of a protein called tau. Tau helps support brain cells, but in Alzheimer’s disease, too much tau can clump together and cause damage which may lead to memory and thinking problems. This medicine is designed to lower the amount of tau so that these harmful clumps form more slowly, which may help slow the disease.

The study aims to understand:
- If LY3954068 is safe for people with Alzheimer’s disease and to see how well people can tolerate it.
- How LY3954068 works inside the body, including what it does and how the body handles it after it is given.

The LY3954068 or placebo is given as an injection into the space around the spine so it can reach the brain more directly.

This study is a double-blind placebo-controlled trial and people in the study will be put into their treatment groups at random. This means:
- Some people will get LY3954068
- Some people will get a placebo (a dummy treatment that has no medicine in it).
- Neither the participant, nor their study doctor will know who is getting which treatment during the first part of the study. This helps make the results fair.

Find more information about why studies use blinding, randomisation and placebo controls.

The study is made up of two parts, A and B.
- Each participant in Part A will receive 1 dose of LY3954068 or placebo (no active drug) given into the spinal fluid.
- Each participant in Part B will receive multiple doses of either LY3954068 or placebo administered into the spinal fluid.
- Participants will also potentially have an opportunity to join a separate study where participants would receive LY3954068.

LY3954068 is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved LY3954068 for the treatment of Alzheimer’s disease.

The study also uses a drug called Flortaucipir F18 to monitor changes in the brain linked to Alzheimer’s disease. Flortaucipir F18 is a special type of medicine that gives off a very small amount of radiation. Medicines like this are called radiopharmaceuticals. Doctors use them before scans to help take clear pictures inside the body. Everyone in the study will have Flortaucipir F18 before their positron emission tomography (PET) scans. 

What will participants be asked to do during the study?

During the study, participants will:
- Have some laboratory tests, such as blood, urine or spinal fluid tests. These tests help doctors check for any new side effects, such as symptoms or health changes that might happen after receiving the study medicines or placebo.

- Have brain scans called PET scans and magnetic resonance imaging (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.

The study will last up to approximately 45 weeks for Part A, and, 100 weeks for Part B, including the screening period.

If participants would like more details about the tests, procedures, or number of visits, the study team can provide full information.

This study is testing a new investigational medicine called RO7812653.

The aim of this study is to compare RO7812653 with a placebo (a dummy medicine) to see:
- How well RO7812653 works
- How safe RO7812653 is in people who have early signs of Alzheimer’s disease.

RO7812653 is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved RO7812653 for the treatment of AD.

How the study is carried out

This study is a double-blind placebo-controlled trial. This means:
- Some people will get RO7812653.
- 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.

People in the study will be put into their treatment groups by chance, like flipping a coin. Most participants will have a 3 in 4 chance of receiving RO7812653 (the study drug) and a 1 in 4 chance of receiving a placebo (a dummy treatment).

For the very first group taking part, the chances are slightly different: they will have a 2 in 3 chance of getting the study drug and a 1 in 3 chance of getting a placebo.

Find more information about why studies use blinding, randomisation and placebo controls.

How is the study treatment given?

RO7812653 or placebo is given as an injection into the space around the spine so it can reach the brain more directly. Participants will be given RO7812653 or placebo once in the study.

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 magnetic resonance imaging (MRI) scans. These scans take detailed pictures of the brain to help doctors check brain health and safety.

- Wear a heart monitor that records your heartbeat so doctors can spot any problems that a quick heart test might miss, like your heart beating too fast, too slow, or feeling like it skips a beat.

- Be admitted to hospital to be monitored immediately before, and for 24 hours after receiving RO7812653 or placebo

- 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.

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.