Alzheimer's
Embark
About this research
In order to participate in this study, you must be able to speak and read Dutch fluently.
Phase IIIb, open-label, multicenter safety study of BIIB037 (aducanumab) in study participants with Alzheimer’s disease who previously participated in the aducanumab studies: 221AD103, 221AD301, 221AD302, and 221AD205.
The study is an open-label continuation of the previous studies where aducanumab was investigated. This study is therefore only accessible to participants who participated in the Emerge study. The purpose of this study is to find out whether a high dose of aducanumab (study drug) is safe and well-tolerated over a longer period of time. It is also being investigated whether the research drug slows down the course of the disease. The study drug is administered via an IV.
You and your research partner come to the research center about 32 times, for about 130 weeks. Each study visit lasts approximately two to six hours, depending on the procedures performed during that visit.
The research is carried out in the Brain Research Center Amsterdam.
This study is commissioned by Biogen.
This text has been directly translated from the Dutch trial description as approved by the Ethical Committee.
Screening – selection
The screening period lasts approximately 12 weeks. During these weeks, multiple examinations and procedures will be conducted to see if you are eligible to participate in the study. These examinations consist of physical and neurological examinations, questionnaires, and tests for your memory, blood tests, heart films (ECGs), and an MRI scan.
Treatment
There is an IV treatment every 4 weeks. During these visits, various investigations and procedures take place, such as for example; physical and neurological examination, blood tests, questionnaires, and tests for your memory, as well as ECGs and MRI scans. The duration of treatment is 100 weeks.
Follow-up
After completion of the treatment phase, there is a follow-up period of approximately 18 weeks. During these visits, questionnaires and tests will be taken for your memory, among other things, blood tests and physical examinations will be carried out.
Who can participate?
- You have a diagnosis of dementia due to Alzheimer’s disease.
- You participated in the Emerge study
- You have someone close to you/a caregiver who can accompany you during the visits to the research center and answer questions about your health and functioning.
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