Alzheimer's
Viviad
About this research
In order to participate in this study, you must be able to speak and read Dutch fluently.
A phase IIb trial, multicenter, randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of the drug PQ912 in participants with mild to moderate Alzheimer’s disease.
The target population for this study is men and women aged 50 to 80 years diagnosed with mild cognitive impairment due to Alzheimer’s disease (MCI) or Alzheimer’s disease.
The research is carried out in the Brain Research Center Amsterdam.
This study is commissioned by Vyvorium.
This text has been directly translated from the Dutch trial description as approved by the Ethical Committee.
Screening – Selection
During a maximum period of six 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. The selection takes place at our location in Amsterdam and includes blood tests, physical examinations, memory tests, and questionnaires.
Treatment
In this study, the study drug is compared with a placebo. The chance that you will receive the study drug compared to placebo is 66%. Participants receive the drug PQ912 in different doses or the placebo (in the ratio 1: 1: 1). Appointments will be made with you when you should come to our center for one of the check-ups (inquiries about side effects and medication use) and physical, neurological, and neuropsychological examinations will take place at various occasoins, in addition to a spinal tap, EEG, ECG, and MRI.
Follow-up
After completing the treatment phase, participants will be followed for up to six weeks and will return to the center once for a final check-up. During this last check-up visit, questionnaires and tests will be taken for your memory, among other things. A final blood test, physical examination, and a spinal tap will be performed.
A total of 14 visits were made to the research center over a period of 6 weeks (screening) and 48-96 weeks (treatment).
Who can participate?
- You have a diagnosis of dementia due to Alzheimer’s disease.
- You are between 50 and 80 years old.
- 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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