Alzheimer's
CogRX
About this research
In order to participate in this study, you must be able to speak and read Dutch fluently.
Phase II study, single-center, randomized, double-blind, placebo-controlled.
The target group for this study is men and women aged 50 to 85 with a diagnosis of mild cognitive impairment or mild-stage Alzheimer’s disease. The duration of the study is approximately 18 weeks.
The study will investigate the safety, tolerability, and immune response of the study drug CT1812 (tablets). This drug is believed to restore synapse function in patients with mild cognitive impairment or Alzheimer’s disease.
This study is commissioned by CogRX.
This text has been directly translated from the Dutch trial description as approved by the Ethical Committee.
Screening – Selection
During a few visits over a period of up to 6 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 in the study. The selection includes a physical and neurological examination, memory tests, questionnaires, blood tests, an MRI scan of the brain, an EEG, and a spinal tap.
Treatment
The research consists of two parts. For a month, half of the group of participants will receive a placebo, and the other group the study drug. After two weeks, this is reversed and the first group receives the study drug and the other group a placebo. You should visit our research center approximately every week during this time. During these visits, various examinations take place, such as: memory tests, blood sampling, a spinal tap, and EEG.
Follow-up
At the end of the period in which you receive the study drug or placebo, final examinations will take place.
Who can participate?
- Age 50 to 85 years
- Men and women with mild cognitive impairment or mild to mild Alzheimer’s disease (diagnosed).
- Women must be infertile, for example through sterilization, because you are past menopause or your uterus and/or ovaries have been removed.
- You have someone in your family or circle of friends who can guide you during the research (research partner).
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