LUMA

In order to participate in this study, you must be able to speak and read Dutch fluently.

The goal of this study is to evaluate how safe and effective the new study drug BIIB122 is for the treatment of participants with early stage Parkinson’s disease. The study compares the effect of the study drug BIIB122 with the effect of a placebo (a drug without an active ingredient, a ‘fake drug’). The study drug is administered orally.

This study is looking at whether the drug BIIB122 can cause the disease to progress more slowly. Microglia cells are activated by inflammation; a number of studies have shown that over-activation of these cells is bad for the brain, and may play a possible role in Parkinson’s disease. BIIB122 reduces the activation of microglia cells.

You will visit the research center approximately 9 up to 20 times, during approximately 55 up to 151 weeks. The actual study duration and number of visits applicable to you will depend on when you start the study. The duration of a visit is not always the same because not every visit has the same procedures. Some of these visits may last 6 hours, others 3.5 hours or shorter. The research takes place in Amsterdam and Zwolle, you choose what is more convenient for you. If you want, someone who knows you well or a family member can come with you during your visits.

This research is commissioned by Biogen.

This text has been directly translated from the Dutch trial description as approved by the Ethical Committee.

You always decide whether you participate in a study. Participation is always voluntary.

1. You apply via the online form, this is non-binding.
2. After application, you are phoned, this is also an opportunity for you to ask questions. During this conversation, we also ask some questions to see whether you are eligible to participate in research. After this conversation, you determine whether you want to progress to step 3.
3. You receive an email with the request to sign a document in which you give permission to retrieve your medical data.
4. When your medical data shows that you meet the requirements to participate in the study, you are invited to a meeting at our location. During this meeting, you receive information and have the opportunity to ask questions, before you decide to participate in research.
5. If you decide to participate in the study, you sign a form and will start the study within several weeks.

1. You always come first – everything we do revolves around you.
2. Experienced team of doctors, neuropsychologists, and nurses.
3. Open and homely atmosphere – this will make you feel relaxed and right at home.
4. Clarity – expert in medicine research which is why you will be well informed during all steps of the process and can always come to us for questions.
5. Always nearby – 3 locations spread through the Netherlands.

• You may experience benefits from a new treatment.
• You will be monitored by a specialized team of healthcare professionals. They can give you advice and monitor whether there is a change in your daily functioning.
• You make a meaningful contribution to a future without Alzheimer’s.
• You contribute to the advancement of science.

You can participate when:

• You have early stage Parkinson’s disease
• You are between 30 and 80 years old.

Are you unsure whether you meet these requirements? Then you can always apply. We will then check together whether you are suitable to participate.