You’ve Got Questions? We’ve Got Answers

The PIA Study is the only clinical trial worldwide targeting Alzheimer’s by preserving the brain’s microvessels and reducing inflammation to support cognition function and memory. Our approach is entirely different from current Alzheimer’s research therapies, which focus on reducing late-stage protein plaques in the brain using monoclonal antibodies. These therapies often come with a number of side effects that are not yet completely understood.

These tasks are designed to be challenging. In fact, most people find some parts of them difficult. We all have mental strengths and weaknesses, so some of the tasks will be easy for you and some harder. It’s normal to not be able to do everything. The important thing is that you try your best to complete what you can.

Yes. You will need to identify a “study partner” to share the clinical trial experience and to facilitate and support your involvement. A study partner should be someone who has frequent contact with you and whom you feel comfortable with. As part of the facilitation role of the study partner, they will provide information about your overall health condition and help report on any side effects or symptoms that you may experience to the study doctor.

Yes. We want you to continue your daily activities as much as possible. At the beginning of the study, there will be a number of visits in a short period of time that you will be required to attend. However, for most of the study there will be about 3 months between visits. We do ask that you continue to take the treatment drug as normal if you go on holidays.

A placebo is an inactive drug or treatment used in a clinical trial. It is sometimes referred to as a “sugar pill.” This means that a placebo has no therapeutic effect. A placebo-controlled trial compares a new treatment with a placebo. It is important to include a placebo in our study, as this will allow us to examine the potential efficacy of Probucol.

An electorcardiogram (ECG) is a painless test that reliably measures the electric waves made by your heartbeat. For the ECG you will be required to remove your top and lie still in a rested position. Sticky patches will be placed on your chest, wrists, and ankles. Wires from the patches link up with the ECG machine, which provide information on the pattern of your heartbeat.

Magnetic resonance imaging (MRI) scans use strong magnets (electromagnetic rays) and therefore are not suitable for everyone. You will be asked questions about whether you could be pregnant, or whether you could have metal in your body. Common items that may mean you cannot have an MRI scan include pacemakers, implanted heart defibrillators, inner-ear hearing aids (cochlear implants), or surgical aneurysm clips.

If you are unable to have an MRI scan this may not necessarily preclude you from the study.

You will be participating in what is described as a double-blinded randomised control study. This means that neither you nor your study doctor will know which treatment you are receiving. You will be randomly assigned to one of two groups, group 1 (placebo) or group 2 (treatment). You will be randomly assigned (by computer) and have an equal chance to be in either group. In certain circumstances like potential safety consideration, your study doctor can find out which treatment you are receiving.

PET scans take different types of pictures to MRI, exploring the abundance of proteins and where they are located. In this study, the PET scan will assess the abundance of a protein called amyloid beta in your brain. Higher amounts of amyloid beta is often found in people with Alzheimer’s disease.

We cannot guarantee or promise that you will receive any benefits from this research; however, the information we get from this research project may help deliver better treatments for people with Alzheimer’s disease. By taking part in this study, you will receive close medical monitoring of your health condition by blood tests and other evaluations during clinic visits.

It is important that your doctor is informed about your involvement in this clinical trial, as you will potentially be taking a new medication. There may also be some instances where we must send the results of your participation to your doctor (required by law).

We will not, however, send any other results of your participation (such as your scores on memory and thinking tasks) to your doctor unless you request for us to do so. Your doctor will need to contact us directly to ask for the release of your results. We will confirm the release of the results with you.

If you decide to take part and later change your mind, you are free to withdraw at any stage. If you choose not to take part, or if you choose to take part and then later withdraw, this will not affect your care. If you decide to withdraw from the clinical trial, we would ask you to notify a member of the research team. This notice would allow that person or the research supervisor to discuss any health risks or special requirements linked to withdrawing. This will not affect your future treatment or your relationship with your study doctor.

If you do withdraw, the study doctor and relevant project team members will not collect additional personal information from you, although personal information already collected will be retained to ensure that the results of the clinical trial can be measured properly and to comply with law.

You should be aware that data collected up to the time you withdraw will form part of the clinical trial results. You will not be identifiable via these results.