Efavirenz

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 drug efavirenz is for the treatment of participants with early stage Alzheimer’s disease. The study compares the effect of the drug efavirenz with the effect of a placebo (a drug without an active ingredient, a ‘fake drug’). The study drug taken in pill form orally.

Recent research conducted at Amsterdam UMC shows that the accumulation of fats, especially cholesterol, is important in the development of Alzheimer’s disease. Efavirenz can remove cholesterol from the brain. This study will see if it leads to preventing, slowing or reversing symptoms consistent with Alzheimer’s disease. It also examines whether the drug helps clear Alzheimer’s proteins from the brain. Efavirenz is not a new drug and is already registered as an antiviral drug.

You and your study partner, someone who knows you well and can answer questions about your daily functioning, will visit the research center approximately 8 times, during approximately 18 weeks. The final visit will 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 1 hour, others 4. The research takes place in Amsterdam.

This study is commissioned by Amsterdam UMC.

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

During a maximum period of a maximum of 12 weeks, it will be determined whether you meet the study criteria and whether your general health allows participation in the study. If so, you can participate. Selection takes place at our locations in Amsterdam, Den Bosch, and Zwolle and includes blood tests, urine tests, physical examinations, memory tests, questionnaires, ECG, MRI (brain scan), and spinal tap.

We treat you for a maximum of 4.5 years with research drugs. The researched drug is called JNJ-63733657. JNJ-63733657 is not approved by any authority yet. Therefore, it can only be used in medical-scientific research like this one.

All references to the word ‘drug’ can refer to JNJ-63733657 or a non-active placebo. A placebo is an inactive substance that is used as a control in clinical research, to determine the effectiveness of the drug. In this research, the placebo will be a liquid that looks exactly like the researched drug and will be administered in the same way but does not contain any active substance. Neither you nor the researcher knows whether you are getting the research drug or the placebo during the study.

The chance that you will receive the research drug is 2 to 3. The research drug will be administered through an IV in your arm. This happens during the treatment every 4 weeks, for a maximum of 59 times. The IV takes about 60 minutes. During and after you get checked by the research team thoroughly.

After the treatment phase is done, participants will be followed for up to 12 weeks and come back to the center for check-ups. During these visits, you will fill in questionnaires. Also, memory tests, blood tests, physical exams, and MRI and/or spinal tap will be done.

• You have a diagnosis of early stage Alzheimer’s disease.
• You are between 55 and 75 years old.
• You have someone close to you/a caregiver who accompanies you during visits, who, among other things, answers questions about your health and functioning.