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ReclutamentoEsplorativo terapeutico (Fase II)Interventistico

Effect of Exenatide on disease progression in early Parkinson’s disease.

Parkinson's disease causes brain cells to slowly stop working, leading to tremors, stiffness, and balance problems. While current treatments help manage these symptoms, they cannot stop the condition from getting worse. This Phase II clinical trial explores whether a medicine named exenatide (brand name Bydureon) can slow down disease progression in people with early Parkinson's disease. Exenatide is an approved treatment for type 2 diabetes, but early laboratory research suggests it might also shield nerve cells from damage. Participants in this study receive regular injections over 21 months. Researchers will track their progress using special brain imaging scans (PET scans), physical movement checks, memory tests, and daily activity trackers. The goal is to see if the drug helps people stay healthier for longer. Taking part is completely voluntary, and participants can continue to work closely with their regular care team.

A colpo d'occhio

Stato
Reclutamento
Fase
Esplorativo terapeutico (Fase II)
Sponsor
Region Stockholm – SLSO
Obiettivo di iscrizione
60
Inizio
20 Dic 2024

Di cosa tratta questo studio?

Parkinson's disease is a condition where nerve cells in the brain gradually become damaged over time. Most existing medicines focus on replacing dopamine, a chemical messenger in the brain, which eases symptoms like shaking, muscle stiffness, and slowed movements. However, these medicines do not stop the underlying loss of nerve cells. Researchers are searching for treatments that can protect brain cells and slow the condition down.

This study tests a medicine called exenatide, given as a long-acting weekly injection using a pre-filled pen. Exenatide is already widely prescribed to help manage blood sugar levels in people with type 2 diabetes. Scientists have found that the drug may also reduce brain inflammation and help nerve cells survive stress, making it an exciting candidate for slowing down Parkinson's disease.

Over the course of 21 months, doctors will closely follow participants to see whether exenatide changes the way the disease develops. They will use specialised PET scans to take pictures of brain activity, alongside regular checks of movement, sleep, mood, and day-to-day quality of life.

By gathering this detailed information, researchers hope to discover whether repurposing an existing, well-understood medicine could provide a new way to help people newly diagnosed with Parkinson's live fuller, more active lives.

Punti chiave

  • Testing whether a diabetes medicine can slow the progression of early Parkinson's disease.
  • The study lasts for 21 months and involves a weekly injection using an easy-to-use pen.
  • Progress is tracked using specialised brain scans, activity sensors, and physical checks.
  • Open to adults aged 18 and older diagnosed with early-stage Parkinson's.
  • Participation is completely voluntary and does not replace your routine NHS healthcare.

Chi può essere idoneo?

This trial is open to adults aged 18 and older who have been diagnosed with early-stage Parkinson's disease. Both men and women can join the study.

Because the study focuses specifically on early disease, doctors will check how recently you were diagnosed and what symptoms you have. They will also review your overall health, including any other medical conditions you may have, to make sure taking part is safe for you.

If you take part, you will need to be able to attend regular hospital appointments over a 21-month period and feel comfortable receiving weekly injections and undergoing imaging scans.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with early Parkinson's disease.
  3. I am able and willing to attend regular clinic appointments over 21 months.
  4. I am comfortable having weekly injections under the skin.
  5. I am able to undergo routine brain scans and blood tests.
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

Taking part in this study lasts for about 21 months. During this time, you will receive a slow-release injection of the study drug once a week using a pre-filled pen. You will have regular appointments at the trial clinic, usually every few months, where the team will monitor your health.

At these visits, doctors will assess your movement, sometimes testing you both before and after taking your normal Parkinson's medications. You will also be asked to wear a small activity tracker on your body to see how you move during everyday life. The trial includes three detailed brain scans (PET scans) to measure how your brain is functioning, alongside routine blood tests and simple questionnaires looking at your memory, mood, sleep, and overall quality of life.

Rischi e benefici potenziali

Taking part may not directly improve your symptoms, but your involvement could help researchers develop new treatments to slow down Parkinson's disease for others in the future. As with any medicine, exenatide can cause side effects. Common ones include mild nausea, reduced appetite, weight loss, and slight irritation or redness where the injection is given. Serious complications are rare, and the study team will monitor you closely throughout. Taking part is entirely voluntary, and you can withdraw from the study at any time without giving a reason and without it affecting your usual NHS medical care.

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Domande comuni

What is exenatide and is it a new medicine?

Exenatide is not a new medicine. It has been used safely for many years to treat type 2 diabetes. Researchers are now testing whether it can also protect brain cells in Parkinson's disease.

Will I have to stop taking my regular Parkinson's medicines?

No, you will usually continue taking your standard treatments. However, for certain check-ups, doctors may ask you to delay your morning dose so they can measure your symptoms before and after medication.

How is the study medicine taken?

The medicine is given as a weekly injection under the skin using a simple, pre-filled pen device. The study team will provide full training on how to use it safely at home.

What is an FDG-PET scan and does it hurt?

A PET scan is a painless imaging test that takes detailed pictures of how your brain cells use energy. It involves lying still in a scanner after receiving a small, safe injection of a tracer dye.

Posso abbandonare lo studio se cambio idea?

Yes. You are free to leave the trial at any point, for any reason. Doing so will not affect your relationship with your doctors or the standard of care you receive.

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