This study will investigate the safety of Xanamem in healthy people without cognitive impairment. The study will also investigate whether treatment with Xanamem improves cognition in these healthy people aged 50 to 80.
Xanamem works by inhibiting an enzyme called 11β-HSD1 which works in the body, and specifically in the brain, to create cortisol, also called the stress hormone. Too much cortisol may contribute to the development of cognitive impairment. By inhibiting the enzyme, and reducing the amount of cortisol in the brain, it is hypothesized that Xanamem could be a potential treatment for mild cognitive impairment.
Who is it for?
You may be eligible for this study if you are:
- Between 50 and 80 years of age without mild cognitive impairment such as memory problems
- Considered healthy (e.g. a healthy weight, no liver problems, no diagnosis of diabetes and/or uncontrolled medical conditions)
- A non-smoker and do not use nicotine-containing products
If you are eligible to be involved in the study, you will be asked to attend the clinic up to 7 times over a period of up to 14 weeks. The clinic visits will take place in the morning (a.m, prior to 12noon). The study consists of three parts: screening (up to 4 weeks), treatment (where you will receive a Xanamem capsule to be taken daily for 6 weeks) and a follow up period (4 weeks). You will be randomly assigned to receive the study medication or a placebo at a 2:1 ratio, respectively. Procedures that will be completed during the study include blood tests, questionnaires, electronic tests (that measure thinking, knowing, remembering, judging, and problem-solving), physical examinations, electrocardiograms (ECGs) on your heart, and measurement of vital signs.
For more information or to apply, see our website for each location:
Central Coast: https://www.paratusclinical.com/clinical-trials-central-coast#!/study/56
Western Sydney: https://www.paratusclinical.com/clinical-trials-western-sydney#!/study/…
This study has been approved by The Bellberry Human Research Ethics committee (reference number: 2021-04-435)