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 TW001 is for the treatment of participants with early stage Alzheimer’s disease. The study compares the effect of the new drug TW001 with the effect of a placebo (a drug without an active ingredient, a ‘fake drug’). The study drug consists of granules which are dissolved in water.
In Alzheimer’s disease, the nerve cells in the brain (neurons) no longer work properly, and may even decrease. This impacts the function of the brain and memory. TW001 contains edaravone, a substance which is used for patients with ALS or who suffered a stroke. Edavarone does two things: it essentially removes toxins from the body, and helps preserve neurons. The way in which edavarone seems to work for ALS and strokes, is comparable to how it could for against Alzheimer’s disease.
You and your study partner, someone who knows you well and can answer questions about your daily functioning, will visit the research center approximately 5 times, during approximately 17 weeks. The final visit can also be done via telephone. 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. A phone call takes around 15 minutes. The research takes place in Amsterdam and Den Bosch.
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.