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RecrutamentoFase IIIIntervencionista

A trial of treatments to slow progression of Parkinson's disease

This study aims to discover new treatments that can slow down the speed at which Parkinson's disease (PD) gets worse. PD is a condition that affects how people move, talk, and think, and it's becoming more common. Current medicines only help with symptoms for a while and can have side effects. This trial is testing two existing medications, telmisartan and terazosin, to see if they can offer more lasting benefits. It’s designed to be efficient, testing several treatments at once against a dummy pill (placebo). This helps researchers quickly find out if a treatment is safe and effective, ultimately hoping to improve the lives of people with Parkinson's.

Em resumo

Status
Recrutamento
Fase
Fase III
Patrocinador
University College London
Meta de inscrição
1,200
Iniciar
01 Sep 2025
Conclusão estimada
30 Jun 2029

Sobre o que é este estudo?

Parkinson's disease is a condition that affects your brain and how you move, talk, and even think. It's becoming more and more common across the UK. While there are treatments available today, they mainly help with the symptoms and don't stop the disease from progressing. Over time, these treatments can also become less effective or cause unwanted side effects. This means doctors and researchers are always looking for better solutions.

This study, called a clinical trial, is focused on finding new ways to slow down how Parkinson's disease progresses. It’s looking at two existing medicines, telmisartan and terazosin, which are already used for other conditions. The idea is to see if these medicines could also be helpful for Parkinson's, potentially offering a new way to manage the disease and improve quality of life for those affected. By testing these medicines, we hope to find drugs that not only help with symptoms but also prevent the disease from getting worse.

The trial uses a clever design where different treatments are tested at the same time in separate groups, rather than one after another. This makes the research faster and more efficient, meaning new discoveries could reach patients sooner. Each new treatment is compared to a 'dummy' pill (called a placebo) to make sure any improvements are really due to the medicine being tested, not just chance. The study will also regularly check how safe a treatment is and if it's showing promise. If it doesn't seem to be working, it can be stopped and replaced with a new one, saving time and ensuring resources are used effectively.

Pontos principais

  • This study aims to slow the progression of Parkinson's disease.
  • It tests existing medicines (telmisartan, terazosin) in a new way for Parkinson's.
  • Most follow-up appointments can be done from home.
  • Potential side effects like low blood pressure will be carefully monitored.
  • Você pode parar de participar a qualquer momento.
  • The study runs until July 2031.

Quem pode ser elegível?

To join this study, you need to have a Parkinson's disease diagnosis from a doctor, neurologist, or someone with similar experience. You must have been diagnosed with Parkinson's when you were 30 years old or older, and there's no upper age limit to take part. You should also have been taking Parkinson's medication (like levodopa or similar drugs) for at least two months before the start of the study.

For everyone joining, we'll need to get your agreement to take part in the study, which we call 'informed consent'. If you're a woman who could become pregnant, you'll need to have a negative pregnancy test before starting. If you (or your partner, if you're a man and your partner could become pregnant) are of child-bearing age, you'll need to agree to use effective contraception throughout the study and for a short time afterwards. There might also be some specific reasons related to the trial medications that mean you can or can't join. That's why we always check carefully.

There are also some reasons why you might not be able to join. These are usually related to other medical conditions or treatments that could make the study medicines unsafe for you. All these details will be discussed fully with you by the study team to make sure it's safe and suitable for you to take part.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Do you have a confirmed diagnosis of Parkinson's disease?
  2. Were you diagnosed with Parkinson's at age 30 or older?
  3. Have you been taking Parkinson's medication for at least 2 months?
  4. Are you able to use contraception if you or your partner could become pregnant?
  5. Are you able to provide your agreement to participate?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part, the first step is an in-person screening visit where we'll check if the study is right for you. This will include a blood test and a heart trace (ECG) for safety. You'll then be given one of the study treatments or a placebo, and we'll follow your progress for up to 36 months (3 years).

After the first visit, most of your follow-up appointments can be done remotely, either by video call or phone. These visits will happen at 3 months, 6 months, and then every 6 months after that, for the whole 36 months. If you prefer to come to the clinic for these visits, you absolutely can, and we'll help cover your travel costs up to £40 per visit. During these check-ups, we'll ask you to fill out questionnaires, assess your Parkinson's symptoms, and discuss any side effects you might be having.

You'll be given a blood pressure monitor to use at home, and instructions on how to use it, as some treatments can affect blood pressure. We'll also ask for two extra blood samples at the start and end of the study for additional research. We'll keep you updated on the study's progress through a website, and the final results will be published. If you have a partner who helps care for you, they could also take part in an optional sub-study by completing some questionnaires about how caregiving affects their quality of life. This is only if you agree to it and your partner is happy to participate.

Riscos e benefícios potenciais

Participating in this study might mean you are among the first to receive a new treatment that could slow down Parkinson's disease, which would be a significant benefit. However, there's no guarantee that the treatment will work for you. The medicines being tested are already used for other purposes, so their safety is generally well understood. The most common side effect we expect is low blood pressure when you stand up (feeling dizzy or faint), but we will provide you with a blood pressure monitor and clear instructions on how to manage this. We'll also discuss how to get in touch with the study team if you experience any symptoms. For women who could become pregnant, or men with partners who could become pregnant, it's important to use contraception during and shortly after the study, as we don't know the effects of these treatments on pregnancy. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (40)

  • Clinical Ageing Research Unit
    Aproximado
    Newcastle upon Tyne, United Kingdom
  • Royal Hallamshire Hospital
    Aproximado
    Sheffield, Reino Unido
  • Hospital Salford Royal
    Aproximado
    Salford, United Kingdom
  • Hospital Queen Elizabeth
    Aproximado
    Birmingham, Reino Unido
  • John Van Geest Centre for Brain Repair site
    Apenas cidade
    Cambridge, United Kingdom
  • University College London Hospital
    Apenas cidade
    Londres, Reino Unido
  • Royal London Hospital
    Aproximado
    Londres, Reino Unido
  • St Georges Hospital
    Apenas cidade
    Londres, Reino Unido
  • John Radcliffe Hospital
    Aproximado
    Oxford, Reino Unido
  • < a>Hospital County Sussex Real< /a>
    Aproximado
    Brighton, United Kingdom
  • Royal United Hospital
    Aproximado
    Bath, Reino Unido
  • Derriford Hospital
    Aproximado
    Plymouth, United Kingdom

Perguntas frequentes

Qual é o principal objetivo deste estudo?

The main goal is to find medicines that can slow down the progression of Parkinson's disease, not just treat its symptoms.

What are 'repurposed drugs'?

These are existing medicines that are already approved and used for other conditions, but researchers are now testing if they can also help with Parkinson's.

Will I have to travel for all my visits?

No, only the first screening visit is in-person. All other follow-up visits can be done remotely by video or phone, or in-person if you prefer.

O que é um 'placebo'?

A placebo is a dummy pill that looks like the real treatment but has no active ingredients. It helps researchers understand if the new treatment is truly effective.

Can my partner join part of the study?

Yes, your partner can optionally complete questionnaires about their caregiving responsibilities, but only if you agree.

Como saber mais

EJS ACT-PD Trial Team at MRC CTU

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

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