This phase III clinical trial is investigating the efficacy and safety of a standardised Chinese herbal formula, Sailuotong (SLT) for vascular dementia or mixed dementia (Alzheimer’s disease with cerebrovascular disease). SLT, a complex combination of ginseng, ginkgo and saffron extracts, has been scientifically developed and tested by a combined team from the China Academy of Chinese Medical Sciences and NICM Health Research Institute at Western Sydney University. Over the last 10 years, SLT has been studied in the laboratory and clinical trials and may improve memory and other cognitive functions.
WHAT'S INVOLVED? This clinical trial is a double blinded study. Participants will be randomly assigned to receive the active study drug or placebo, and will be instructed to take it for a 52 week period. Over 65 weeks, participants will need to attend eight scheduled clinic visits where they will be assessed by the research team, have blood tests, and complete several questionnaires.
WHAT ARE THE BENEFITS TO PARTICIPATING? Participants will be reimbursed for their travel costs at each clinic visit. When participants complete the trial, they are eligible to receive a 12 month complimentary supply of SLT and will have their health monitored during this time.
WHO CAN JOIN? Men and women over 40 years who can understand, read and write basic English and:
- Who have been diagnosed with mild-to-moderate vascular dementia or Alzheimer’s disease with cerebrovascular disease
- Are taking medications for the treatment of dementia, the dose must be stable for at least 6 months
- Who are willing to take the trial medicine every day for 12 months
- Are willing to attend 8 clinic visits over a 65 week period with their carer at one of our trial sites in Sydney, Wollongong, Lismore, Canberra, Brisbane, Melbourne or Adelaide
This clinical trial has been approved by the Human Ethics Committees of South Western Sydney Local Health District Human Research Ethics Committee (HREC/14/LPOOL/81), Western Sydney University (Approval Number: H11554), NSW Guardianship Tribunal (Approval Number: 1/2015), Specialist Services Medical Group Research and Ethics Committee, Southern Cross University Ethics Committee (ECN-17-221).