A clinical study that is testing a new herbal medicine formula treatment for vascular dementia or Alzheimer’s disease with cerebrovascular disease.
About this study
The research study is testing a new treatment for vascular dementia (VaD) and Alzheimer’s disease with cerebrovascular disease. The new treatment is called sailuotong (SLT). SLT is an extract of three standardised Chinese herbs, ginseng, ginkgo and saffron, all of which are individually permitted for over-the-counter sale in Australia.
The primary objective is to determine the effectiveness of the herbal intervention on cognitive function (the brain functions relating to attention, memory, judgement, reasoning and problem-solving), activities of daily living and quality of life, and monitor the safety and effectiveness of SLT.
Anticipated enrolment close date: Ongoing
Who can take part
To participate in this study, participants must be:
- Over 40 years old
- Diagnosed with either VaD or Alzheimer’s disease with evidence of cerebrovascular disease
- Be on stable medications (if present) for at least three months before inclusion in the study
- Have a study partner who is in contact with the participant at least 2 days a week
What's involved
Participation will involve taking the treatment for 52 weeks, and attending 8 scheduled clinic visits and one scheduled telephone call over 65 weeks.
The procedures that will occur over the duration of the study include:
- Blood and urine tests
- Vital signs and electrocardiograms (ECGs)
- Physical and neurological examination
- Questionnaires, worksheets, puzzles to test cognitive function
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.