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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?
This study is testing a new medicine called SAR448851 to see if it can slow down or slow the progression of early Alzheimer's disease (AD). Alzheimer's disease is a brain condition that causes memory loss, thinking problems, and difficulties with daily activities, affecting millions of people worldwide.
SAR448851 works by helping a protein in the brain called TREM2. TREM2 helps the brain clean away harmful substances that can build up and cause problems. Some people have changes in the TREM2 gene that make them more likely to develop Alzheimer's disease. Early studies suggest that helping TREM2 work better may protect the brain and reduce damage caused by Alzheimer's disease.
What will participants be asked to do during the study?
The study drug is a tablet to be taken on an empty stomach – you cannot eat for three hours before and two hours after the study drug. You will be in the study for about two years (102 weeks) including a six-week follow-up after completing treatment.
The study visits and procedures are described below.
Screening is made up of three site visits, procedures include: memory tests, reviewing medical history, physical exam, blood/urine tests, blood sample for gene testing, plasma amyloid test, ECG, MRI brain scan and PET brain scan.
Baseline visit is made up of two onsite visits, procedures include: PET brain scan, lumbar puncture, memory tests, blood tests.
Treatment period is then comprised of 22 visits across two years (15 onsite and seven remote) all of which require a study partner.
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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.
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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.