Alnylam

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 investigational medication, ALN-APP, is for the potential treatment of participants with MCI or mild dementia due to early onset Alzheimer’s disease. Early onset Alzheimer’s disease is diagnosed in men and women younger than 65 years old. The study compares the potential effect of the ALN-APP with the effect of a placebo (an injection without an active ingredient, a ‘fake drug’). The study medication is administered through an injection.

Too much of the amyloid protein in the brain is seen as a possible cause of Alzheimer’s by many scientists. The intent of the investigational medication, ALN-APP, is to reduce the production of a protein called “Amyloid Precursor Protein (APP)”, thus addressing the excessive production of amyloid at the source. To participate in the study, there must be an elevated level of amyloid protein in the brain. If not already known, tests will be performed to determine the presence of amyloid.

You and your study partner, someone who knows you well and can answer questions about your daily functioning (such as a partner, family member, friend, caregiver), will visit the research center approximately 23 times, over approximately 152 weeks. In addition, you will also have several telephone conversations. 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. A phone call takes around 15 minutes. The research takes place in Amsterdam.

This research is commissioned by Alnylam.

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 Alzheimer’s or mild dementia due to early onset Alzheimer’s disease
• You are older than 18.
• You have someone close to you/a caregiver who can accompany you during the visits to the research center and can answer questions about your health and functioning, among other things.

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