About this research
In order to participate in this study, you must be able to speak and read Dutch fluently.
Cognitive Run In period (CRI period – Cognitive Run In period)
The aim of this study is to enable the researchers to start collecting and studying data (information) from participants in the study. This includes personal information, how the disease occurs in your family, your cognitive functions and biomarkers and the changes in these. This gives the researchers an idea of the course of the disease per participant without medication and offers participants the opportunity to become familiar with what participation in the clinical trial entails.
The CRI period takes place prior to the start of the actual research with treatment groups. You will not be given any research drug in the CRI examination.
The duration of the investigation of the CRI period depends on when a decision has been made which investigational agent will be tested.
This study is commissioned by Washington University.
This text has been directly translated from the Dutch trial description as approved by the Ethical Committee.
Screening and visits
During the screening period, it is determined within 8 weeks whether you meet the research criteria and also whether your health allows participation in the research. If so, you can participate in the study.
Then a “baseline measurement” is taken. This includes blood tests, physical examinations, memory tests, questionnaires, an MRI scan, and a PET scan.
Thereafter, study visits take place approximately every 12 weeks for the remainder of the study. Depending on the procedure and the type of study visit, procedures may be performed at your home or at the Brain research center, and their length may vary.
Extensive examinations take place every year in which information is collected about your health with physical and neurological examinations, an ECG (heart film), memory tests, questionnaires, an MRI, and a PET scan. These appointments can be spread over 2 days. Participation is voluntary at all times.
Who can participate?
- There is a genetic variant of Alzheimer’s disease in your family
- And know that you yourself are a mutation carrier
- And you don’t know and don’t want to know
- You are between 18 and 80 years old
- You do not yet have symptoms consistent with Alzheimer’s disease
- Or you already have symptoms (maximum 10 years),
- In this case, the possible use of Alzheimer’s medication is allowed
- You have a family carer who can accompany you during a few visits to the research center and answer questions about your health and functioning, among other things.
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