A clinical trial that aims to assess the safety and efficacy of a new drug (ANAVEX®2-73) for the treatment of early Alzheimer’s disease.
About this study
The main aim of this study is to investigate the effectiveness of a new drug (ANAVEX®2-73) in treating early Alzheimer’s disease. Two clinical studies investigating use of ANAVEX®2-73 in human subjects have been completed and have shown positive outcomes in cognition, such as memory, attention, speed of processing and reasoning and problem-solving.
The current study extends on previous findings to further investigate the effect of this drug (including at varying dose levels) on cognitive and functional outcomes – the former being various aspects of thinking abilities and the latter being independence in completion of daily activities.
Who can take part
To participate in this study, the potential participant must:
- Be between 60 and 85 years of age
- Have a diagnosis of either mild cognitive impairment due to Alzheimer's or mild Alzheimer's disease
- Have a study partner who is able to spend at least 10 hours weekly with you
- Be on stable medications for at least 3 months
- Be able to attend visits at the RMH Parkville
What's involved
Participation will involve being on the investigational drug for 48 weeks and attending 6 scheduled clinic visits and 1 scheduled telephone call. Procedures that will occur during clinic visits and over the duration of the study include:
- Blood and urine tests
- Vital signs and ECGs
- Physical and neurological examination
- Completion of questionnaires
- Assessment of thinking abilities
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.