Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease

This research study is for people in the early stages of Parkinson's disease. The main goal is to understand more about a new treatment called ACI-7104.056. We will be looking at how safe it is, if it causes any side effects, and how the body handles the medicine. Some participants will receive the active treatment, while others will receive a placebo, which looks identical but contains no medicine. This helps us compare the effects fairly. All treatments are given as injections. The study will last for quite a while, including an initial check-up period, over a year of treatment, and a monitoring period afterwards to see how everyone is doing.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AC Immune SA

Enrolment target

150

Start

24 Jul 2023

Estimated completion

01 Jan 2028

Parkinson Disease Parkinson Disease 6, Early-Onset

What is this study about?

This research study is about finding new ways to help people with Parkinson's disease, particularly those who are in the early stages. Parkinson's is a condition that affects the brain and can cause problems with movement, like shaking, stiffness, and difficulty with walking. Currently, treatments can help manage the symptoms, but scientists are always looking for ways to slow down or even stop the progression of the disease.

In this study, we are focusing on a potential new treatment called ACI-7104.056. The main things we want to learn are: Is it safe for people to take? How does the body react to it? Does it cause any unwanted side effects? And does it have any noticeable effects on Parkinson's disease itself? By understanding these points, researchers can decide if this new treatment has the potential to become a helpful medicine in the future.

Taking part in studies like this is really important because it helps medical science advance. Every new medicine we have today started with research like this, where brave volunteers helped us learn what works and what doesn't. Your participation could contribute to better treatments for people with Parkinson's disease for years to come.

Key takeaways

This study is for people recently diagnosed with early Parkinson's disease.
It tests a new medicine called ACI-7104.056 given by injection.
The study aims to check safety, how the body handles the medicine, and its effects.
Participants will receive either the active medicine or a dummy treatment (placebo).
The study involves about 1.5 years of treatment and 6 months of follow-up.
Participation is voluntary, and you can stop at any time.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with Parkinson's disease fairly recently, specifically within the last two years. Doctors would need to confirm that your Parkinson's is indeed early-stage.

You should be between 40 and 75 years old and weigh between 45 kg and 110 kg (about 7 stone to just over 17 stone). You would also need to be taking a stable dose of L-Dopa (a common Parkinson's medicine) at 300 mg per day, and your doctor should feel that dose is unlikely to change over the next year or so.

There are also some other general health requirements, including having a brain scan that supports the diagnosis of Parkinson's, and being able to understand the study information and agree to take part. For women who could become pregnant, special contraception rules apply, and men must also use contraception with their female partners and not donate sperm during the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 75 years old?
Have you been diagnosed with Parkinson's disease in the last two years?
Do you currently take L-Dopa at 300 mg per day?
Do you weigh between 45 kg and 110 kg?
Are you able to attend regular appointments for injections and check-ups for about two years?
If you are a woman who could become pregnant, are you willing to use highly effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study starts with a 'screening period' that can last up to 8 weeks. During this time, you'll have tests and check-ups to make sure the study is right for you. Once accepted, you'll enter the 'treatment period' which lasts for about 74 weeks, or just over a year and a half. During this time, you'll receive regular injections of either the study medicine (ACI-7104.056) or a placebo (a dummy injection that looks the same but contains no active medicine). You won't know which one you're getting, and neither will the study doctors – this is to make sure the results are fair.

After the treatment period, there's a 'follow-up period' of about 26 weeks, or roughly six months. During this time, you won't receive injections, but you'll have check-ups to see how you're doing. This whole process, from your first screening visit to the final follow-up, could last for approximately 108 weeks, which is about two years.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive access to a new treatment that isn't yet widely available, which could potentially help your Parkinson's symptoms. However, as this is an early-stage study, it's also possible that the treatment might not be effective for you, or it could cause side effects. Possible risks could include discomfort from injections, and any side effects related to the study medicine that we are still learning about. You will be closely monitored by doctors and nurses throughout the study. Remember, if you decide to join, you always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Katholisches Klinikum Bochum GmbH
Verified postcode
Bochum, Germany
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
Verified postcode
Kassel, Germany
University Medical Centre Schleswig-Holstein
Verified postcode
Kiel, Germany
Hospital De La Santa Creu I Sant Pau
Verified postcode
Barcelona, Spain
Hospital Universitari Vall D Hebron
Verified postcode
Barcelona, Spain
Policlinica Gipuzkoa
Verified postcode
Donostia / San Sebastian, Spain
Hospital Universitario De La Princesa
Verified postcode
Madrid, Spain
Hospital Universitario Puerta De Hierro De Majadahonda
Verified postcode
Majadahonda, Spain
Hospital Universitario Quironsalud Madrid
Verified postcode
Pozuelo de Alarcón, Spain
King's College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom
Re:Cognition Health Limited
Verified postcode
London, United Kingdom
Northern Care Alliance NHS Foundation Trust
Verified postcode
Salford, United Kingdom

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain, causing problems with movement, such as shaking, stiffness, and difficulty balancing.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the actual drug fairly.

How will I receive the study medicine?

The study medicine or placebo will be given as injections into a muscle.

How long will I be in the study?

The entire study, including initial checks, treatment, and follow-up, could last for about two years.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctors will know if you're receiving the real medicine or the placebo. This is a standard way to make sure the study results are fair and unbiased.