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 drug neflamapimod is for the treatment of participants with dementia with Lewy bodies (DLB). The study compares the effect of the new drug neflamapimod with the effect of a placebo (a drug without an active ingredient, a ‘fake drug’). The study drug are capsules that you take with food.
This study will try to determine if neflamapimod can improve memory and attention in people with Lewy bodies dementia. The study drug neflamapimod blocks a certain protein in the brain. This protein causes inflammation reaction in the brain which is stopped by the study drug. By blocking this protein there will be less damage in the brain and therefore there will be less memory and attention problems for people with DLB.
You and your study partner, someone who knows you well and can answer questions about your daily functioning, will visit the research center approximately 9 times, spread over 21 weeks. After completing the main study, there is also an extension study you could participate in. If you participate in the extension study, you will visit the research center 6 more times, spread over 34 weeks. The duration of a visit is not always the same because not every visit has the same procedures. Some of these visits may last 2 hours, others 1 hour. The research takes place in Amsterdam, Den Bosch or Zwolle. U can choose at which research center you participate.
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.
You receive an email with the request to sign a document in which you give permission to retrieve your medical data.
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.
If you decide to participate in the study, you sign a form and will start the study within several weeks.
The goal of this study is to evaluate how safe and effective the new drug neflamapimod is for the treatment of participants with dementia with Lewy bodies (DLB). The study compares the effect of the new drug neflamapimod with the effect of a placebo (a drug without an active ingredient, a 'fake drug'). The study drug are capsules that you take with food.
Dementia with Lewy bodies
Study days are spread over 21 to 55 weeks
Amsterdam, Den Bosch or Zwolle
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