Study on the Safety and Effects of ACI-7104.056 in Patients with Early Parkinson’s Disease

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What is this study about?

This clinical trial is focused on studying the early stages of Parkinson’s disease, a condition that affects movement and can cause tremors, stiffness, and difficulty with balance and coordination. The study is testing a new treatment called ACI-7104.056, which is a vaccine designed to help the body produce antibodies that may protect against the progression of Parkinson’s disease. The trial will also use a placebo, which is a substance with no active medication, to compare the effects of the vaccine.

The purpose of the study is to evaluate the safety and how well the vaccine is tolerated by patients, as well as to see how the body responds to it. Participants will receive the vaccine or placebo through an injection into the muscle. The study will also involve the use of DaTSCAN, a special imaging technique that helps visualize certain areas of the brain, to monitor changes over time. This imaging involves a solution called ioflupane (123I), which is injected into a vein to help highlight brain structures during the scan.

Throughout the study, participants will have regular check-ups, including physical and neurological exams, and will be monitored for any side effects. Blood and urine tests will be conducted to ensure safety, and participants will be asked about their overall well-being. The study will last for several weeks, with follow-up visits to track progress and gather important data on the vaccine’s effects. This research aims to provide valuable insights into the potential benefits of the vaccine for people with early Parkinson’s disease.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, a detailed medical history will be taken, and a physical and neurological examination will be conducted.

You will undergo routine laboratory tests, including blood and urine samples, and a brain MRI will be performed. An electrocardiogram (ECG) will also be conducted to check your heart’s health.

2 screening

A screening brain DaT-SPECT will be performed to confirm the diagnosis of early-stage Parkinson’s disease.

If you are a female participant of childbearing potential, a blood pregnancy test will be conducted. You will need to use highly effective contraception methods during the study.

3 randomization

You will be randomly assigned to receive either the study vaccine ACI-7104.056 or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you receive.

4 treatment administration

The study vaccine or placebo will be administered as an intramuscular injection. The exact dosage and frequency will be determined by the study protocol.

You will continue your current treatment with L-Dopa at 300 mg per day, maintaining a stable dose throughout the study.

5 follow-up visits

Regular follow-up visits will be scheduled to monitor your health and the effects of the treatment. These visits will include physical and neurological examinations, laboratory tests, and assessments of any side effects.

Your antibody response to the study vaccine will be evaluated through blood tests.

6 imaging and assessments

At 48 weeks and 100 weeks, a follow-up DaT-SPECT will be conducted to assess changes in your brain.

Your motor symptoms will be evaluated using the MDS-UPDRS Part III score over the course of 100 weeks.

7 end of study

At the end of the study, a final assessment will be conducted, including all necessary examinations and tests to ensure your well-being.

You will be informed about the treatment you received and any relevant findings from the study.

Who Can Join the Study?

Have a confirmed diagnosis of early stages of idiopathic Parkinson’s Disease (a type of Parkinson’s Disease with no known cause) for no more than 2 years.
Currently taking a single medication called L-Dopa at 300 mg per day, with a stable dose for at least 3 months before starting the study. The likelihood of needing a dose change in the next 6 to 12 months should be low.
Can be either male or female.
Be aged between 40 to 75 years.
Have a body weight between 45 kg to 110 kg (99 to 242 lbs) and a body mass index (BMI) between 18 to 34 kg/m².
Have a Modified Hoehn-Yahr Stage of I to II, which is a scale used to describe the progression of Parkinson’s Disease.
Have a brain scan called DaT-SPECT that is consistent with Parkinson’s Disease.
Be able to understand and sign the informed consent form, and be willing to follow the study rules.
If female, must be postmenopausal for at least 1 year, surgically sterilized, or have a negative pregnancy test and use effective birth control during the study. If male, must use condoms with spermicide and ensure female partners use effective birth control during the study. Men should not donate sperm during the study.

Who Cannot Join the Study?

Patients who do not have the early stages of idiopathic Parkinson’s Disease cannot participate. Idiopathic means the cause of the disease is unknown.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.
Patients who are part of a vulnerable population may not be eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
Patients who do not meet other specific health criteria set by the study may be excluded. These criteria are not listed here, but they are important for ensuring the safety and effectiveness of the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Policlinica Gipuzkoa S.A.	Donostia / San Sebastian	Spain
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA	Osnabrück	Germany
Hnshhvrm Dv Ly Sxpfl Cjop I Sjms Peb	Barcelona	Spain
Hcxzgltd Uzhseubzcavsw Dn Lb Pnzxuyhc	Madrid	Spain
Hbqbyviv Vjwk dirvdvsx	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	26.09.2022
Spain	Recruiting	26.09.2022

Trial locations

Investigated drugs:

ACI-7104.056 is a study vaccine being tested in patients with early stages of Parkinson’s disease. This vaccine is designed to help the body produce antibodies, which are proteins that can recognize and fight off certain substances. The main goal of using this vaccine in the trial is to see if it is safe for patients and to understand how well it can trigger the body’s immune response. Researchers are looking at how the vaccine affects the body and whether it can help manage symptoms or slow down the progression of Parkinson’s disease. The trial is focused on understanding the vaccine’s safety and how well it is tolerated by patients, as well as measuring the immune response it generates in the blood.

Investigated diseases:

Parkinson's disease

Idiopathic Parkinson’s Disease – Idiopathic Parkinson’s Disease is a progressive neurological disorder characterized by the degeneration of dopamine-producing neurons in the brain. This leads to symptoms such as tremors, stiffness, slowness of movement, and balance difficulties. As the disease progresses, these motor symptoms typically worsen, and non-motor symptoms like sleep disturbances, mood changes, and cognitive impairment may also develop. The progression of symptoms varies among individuals, with some experiencing a gradual decline while others may notice more rapid changes. The early stages often involve mild symptoms that may not significantly impact daily activities. Over time, the disease can lead to increased difficulty in performing everyday tasks.

Trial ID:

2022-500292-31-00

Protocol code:

ACI-7104-PD-2103

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of ACI-7104.056 in Patients with Early Parkinson’s Disease

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