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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.

What is the aim of the study? 

The aim of AD-SMART is to test different medications for the treatment of Alzheimer’s disease by comparing them to a dummy medication (placebo). This study will look at how these medications affect memory and thinking, as well as the ability to carry out activities of everyday living, over time, with assessments carried out at regular points during the study.

What will participants be asked to do?  

Eligibility screening: not everyone may be able to take part in the study, therefore, we need to do some tests first to see whether you are able to take part. These are known as “eligibility screening tests’’. We will also do an eligibility test on your study partner by asking a few questions. 

Randomisation: if you’re eligible, and agree to take part, a computer will randomly assign you to one of the groups. You will receive either one of the two medications being tested or a dummy pill (placebo).  You, your study partner, or your doctor or study team will not know what medication you are receiving or if you are receiving the dummy pill. 

Study medication: the study medication will be posted to you, and you will continue with your usual care. AD-SMART is starting with medications that are already used for other conditions. These are called “repurposed” treatments. This means we already know they are safe to use, which can make the development of new treatments faster and more efficient. You will be asked to take medication every day according to a schedule for a maximum of 18 months.

The first AD-SMART medications are: 

• atomoxetine - currently used to treat Attention Deficit Hyperactivity Disorder (ADHD)
• metformin - currently used to treat a type of diabetes
• a dummy drug (called a placebo) which looks like the trial medication but does not contain any medicine - it is important to include a dummy drug in the trial design to allow a direct comparison of whether the other drugs are proving to be beneficial.

Study partner: you will need a study partner to take part in this study. This can be a family member or a close friend who knows you well. They will answer questions about how you’re doing at different points during the study. 

Future visits: as part of the study, you will have regular follow-up over a period of 18 months and your study partner will be attending these visits with you. You will be asked to come into the clinic at the start for screening tests. You will also be asked to come in when all the tests show that you are eligible to join the study to confirm that you are happy to continue and to complete some questionnaires and assessments. There will be phone or video calls at 3, 9 and 15 months to assess how you are getting along and whether you have missed any doses or experienced any side effects. There will be clinic visits in-person at 6, 12 and 18 months. During these in-person visits, a qualified person from the study team will take your blood for safety tests and additional study specific blood tests. You will be asked about how you are doing on the medication and whether you have missed any doses or experienced any side effects. You will also be asked to perform memory and thinking tasks.
You may be asked to have an MRI, if it is safe for you to do so, at your screening visit. At the end of the study, you will be asked to have another MRI. 





 

What is the aim of the study? 

To investigate whether a drug called tadalafil is safe to be used in patients with mild Alzheimer’s disease and whether it helps slow progression. Tadalafil is a drug that has been on the market for around 20 years. It has previously been used to treat a heart condition called pulmonary hypertension and is also used to treat 
erectile dysfunction. It has been noted in the past that tadalafil may be associated with a lower risk of memory issues such as Alzheimer’s, possibly by increasing blood flow to the brain and reducing inflammation. We want to test this theory formally in a large research trial.  

What will participants be asked to do during the study? 

Participants will be asked to attend for a screening visit. The screening visit will involve memory tests and blood tests. If accepted onto the trial, there is a baseline visit. Here, we do more comprehensive memory tests and 3 different types of scans (MRI, DCE-MRI, and PET-CT). There is an option to have a lumbar puncture (a needle into the back to sample brain fluid), but this is optional.  After this, participants will be randomised to either tadalafil or a dummy pill (placebo). Participants will have a 50% chance of being on tadalafil vs placebo. Find more information about why studies use blinding, randomisation and placebo controls.

Participants will take the tablets for a year. There will be multiple visits to check up on participants - at 2 weeks (over the phone), 1 month, 3 months, 6 months, 9 months, and 12 months. Blood pressure will be monitored carefully, because tadalafil can sometimes cause low blood pressure.  

After a year, participants will finish their medication and the scans (MRI, DCE-MRI and PET-CT), memory tests and blood tests will be repeated.  
In total, there will be around 8 visits. 

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 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.