Noradrenaline treatment of apathy and impulsivity in participants with Progressive Supranuclear Palsy syndromes
Progressive Supranuclear Palsy (PSP) is a condition that affects balance and movement, but it can also cause changes in behaviour. Many people experience a loss of motivation (apathy) or act without thinking (impulsivity). These changes can be difficult for both patients and their families, and they may be linked to low levels of a brain chemical called noradrenaline. This study tests whether a medicine called atomoxetine can safely restore these chemical levels and help with behavioural symptoms. Atomoxetine is already used for other medical conditions. During the study, everyone will try the real medicine for eight weeks and a dummy pill (placebo) for eight weeks, separated by a short break. You and a family member or carer will attend hospital visits to complete simple memory tests and questionnaires, helping researchers learn if atomoxetine could be a helpful treatment.
A colpo d'occhio
Di cosa tratta questo studio?
Progressive Supranuclear Palsy (PSP) is an uncommon brain condition. While it is best known for causing problems with walking, balance, and eye movements, it also affects how people feel and act. Many people with PSP experience severe apathy, which means losing motivation or interest in activities they once enjoyed. Others may show impulsivity, meaning they act quickly on impulse without considering risks. These changes happen because of changes in the brain, but they can be very stressful for individuals and their carers.
Scientists believe these behavioural symptoms occur partly because the brain loses a natural chemical called noradrenaline. Noradrenaline helps control attention, motivation, and decision-making. This clinical trial is testing whether a drug called atomoxetine can boost noradrenaline levels in people with PSP. Atomoxetine is already widely used for other conditions, but doctors need to find out if it is safe, well-tolerated, and helpful for people living with PSP.
Because this is a 'crossover' study, every participant will have a turn taking atomoxetine and a turn taking a harmless dummy pill (placebo). Neither you nor your research doctor will know which pill you are taking first. This setup allows researchers to compare the effects fairly and ensures nobody misses out on trying the actual medication.
Punti chiave
- The study tests whether atomoxetine can help with apathy and impulsivity in PSP.
- Every participant gets to try both the real medicine and a dummy pill for eight weeks each.
- You need a carer or family member to join as your research partner.
- The trial takes about 22 weeks and involves six visits to the study hospital.
- Taking part is completely voluntary and you can withdraw at any time.
Chi può essere idoneo?
This study is open to adults aged between 50 and 85 who have been diagnosed with Progressive Supranuclear Palsy (PSP). To take part, you must have the mental capacity to understand the study and agree to join. You will also need a 'research partner'—such as a relative, close friend, or carer—who sees or speaks to you regularly and is willing to answer questions about your daily life and wellbeing.
To ensure your safety, your regular medications must be stable for at least four weeks before joining the study, with no planned changes to any brain-related medicines. You should also be generally well enough to attend hospital appointments.
You cannot take part if you are pregnant or breastfeeding. Women who could become pregnant will need to take routine pregnancy tests during the study. If you have other severe medical conditions that make taking part unsafe, the study doctors will discuss this with you.
Questo studio potrebbe fare al caso tuo?
Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.
- I have been diagnosed with Progressive Supranuclear Palsy (PSP).
- I am aged between 50 and 85 years old.
- I have a family member, friend, or carer who can attend study visits with me.
- My current medications have been stable for at least 28 days.
- I am able to give informed consent and attend hospital appointments in the UK.
Cosa comporta la partecipazione?
Taking part in this study lasts for around 22 weeks and involves six visits to a study hospital. At your first visit, the team will explain the study in detail, check your health, and ask you and your research partner to sign consent forms. You may also choose to have an optional brain scan (MRI) or blood tests.
Next, you will be given your first set of pills to take at home for eight weeks. By chance, like tossing a coin, you will receive either atomoxetine or a dummy pill. You will visit the hospital at the start and end of this period for simple questionnaires, health checks, and thinking tasks. You will then have a two-week break where you stop study pills and only take your usual medicines. After this break, you switch over: if you had the dummy pill first, you will now take atomoxetine, and vice versa, for another eight weeks. Finally, four weeks after finishing your second course of pills, you will have one last hospital visit for closing health checks.
Rischi e benefici potenziali
Luoghi (7)
- Cambridge University Hospitals NHS Foundation TrustSolo cittàCambridge, England
- The Newcastle Upon Tyne Hospitals NHS Foundation TrustSolo cittàNewcastle-upon Tyne, England
- Fondazione Trust dell'Ospedale Universitario di Southampton NHSSolo cittàSouthampton, England
- Ospedale Salford RoyalApprossimativoSalford, England
- John Radcliffe HospitalApprossimativoOxford, England
- Ospedale Reale di GwentNon verificatoNewport, Wales
- Ospedale Universitario Queen ElizabethNon verificatoGlasgow, Scotland
Domande comuni
Will I definitely receive the study medication?
Yes. This is a crossover study, which means every person who completes the trial will take the real medicine (atomoxetine) for eight weeks and the dummy pill for eight weeks at different times.
What is a research partner and why do I need one?
A research partner is a relative, friend, or carer who knows you well and is in regular contact. They help by attending visits, supporting you, and answering simple questionnaires about any changes in your behaviour or daily life.
Do I have to stop taking my regular medicines?
In most cases, no. You can usually carry on with your usual medications, but they must have been at a steady dose for at least four weeks before you begin the trial.
Are the hospital visits painful or difficult?
Most visits involve simple health checks, blood pressure measurements, and completing puzzles or questionnaires. Optional parts, like an MRI scan or giving a blood sample, are not mandatory to take part.
Can I leave the study early if I want to?
Yes. You can leave the study at any time, for any reason. Your decision will never affect the standard medical care you receive from the NHS.
Come saperne di più
James Rowe
Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.
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