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Xanamem™ in Healthy Elderly Subjects (XanaHES)
Xanamem™ is being developed as a potential drug for Alzheimer's disease. This study drug has been designed to change the cortisol levels in the brain. Cortisol is a naturally occurring hormone in the body. It is believed that reducing the level of cortisol will be a benefit in the treatment of Alzheimer's disease. The XanaHES study is testing the safety and tolerability of Xanamem. It is planned to enrol approximately 84 participants, male and female aged from 50 to 75 who are in good health, in the study at 1 centre in Australia. The XanaHES Phase I study is a single-blind study. Subjects will be randomised to receive either 20mg once daily Xanamem or Placebo in cohort 1. Once all subjects have completed the study treatment of 12 weeks, a dose escalation committee will decide if a new cohort, cohort 2, with 30mg once daily vs placebo is started.
Details
| Lead sponsor | Actinogen Medical |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 42 |
| Start date | Mon Jan 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Jan 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Safety
- Peripheral Neuropathy
- Cortisol
- Central Nervous System
- Cognitive Function
- Healthy Ageing
- Small Fibre Neuropathy
- Cerebrospinal Fluid
- Electrocardiography
Interventions
- Xanamem
- Matching Placebo
Countries
Australia