In order to participate in this study, you must be able to speak and read Dutch fluently.
A phase II, double-blind, randomized, placebo-controlled study, parallel-group, multicenter research on the safety and effectiveness of JNJ-63733657. A monoclonal anti-tau-antibody, to be tested with participants in the early stages of Alzheimer’s disease.
The goal of the research is to find out how safe and effective the new drug JNJ-63733657 is for the treatment of participants with early stages of Alzheimer’s disease, defined as mild cognitive impairment and mild dementia caused by Alzheimer’s. The early stages of Alzheimer’s are the beginning of the sickness, where the participant, for instance, suffers from memory loss but remains independent, or whose daily functioning is slightly reduced. We compare the effect of JNJ-63733657 with a placebo. A placebo is a drug without an active substance, a “fake drug”.
The research will take place in Brain Research Center Amsterdam, Den Bosch, and Zwolle.
This study is commissioned by Janssen.
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.