The purpose of this research is to investigate the efficacy and safety of a standardised Chinese herbal medicine formula in the treatment of patients with vascular dementia or Alzheimer's disease with cerebrovascular disease (mixed dementia). This study is of clinical significance because viable pharmaceutical options are currently lacking and do not appear to address the complex nature of vascular dementia.
Who can join?
- Men and women over 40 years who can understand, read and write basic English.
- Participants who have been diagnosed with mild-to-moderate vascular dementia or Alzheimer’s disease with cerebrovascular disease.
- Participants taking medications for the treatment of dementia, the dose must be stable for at least 6 months.
- Participants who are willing to take the trial medicine every day for 12 months.
- Participants and their carer(s) who are willing to attend 8 clinic visits over a 65 week period at one of our trial sites in Sydney, Wollongong, Lismore, Canberra, Brisbane, Melbourne or Adelaide.
This clinical trial is a double-blinded study, meaning that participants and their study doctors will not know which treatment is being received. Participants will be randomly assigned to receiving the active study drug or placebo, and will be instructed to take it for a 52 week treatment period.Over a 65 week period, participants will:
- have one scheduled telephone call.
- attend eight scheduled clinic visits, where participants will be:
- assessed by the research team.
- have blood tests.
- asked to complete several questionnaires.
What are the benefits of participating?
- Participants will be reimbursed for their travel expenses to clinic visits.
- 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.
Download the research flyer (PDF, 662.59 KB).(opens in a new window)
Interested in participating?
For further information please phone the trial hotline on (02) 4620 3578 or email firstname.lastname@example.org.
This clinical trial has been approved by the Human Ethics Committees of Western Sydney University (Approval Number: H11554), South Western Sydney Local Health District Human Research Ethics Committee (HREC/14/LPOOL/81), NSW Guardianship Tribunal (Approval Number: 1/2015), Specialist Services Medical Group Research and Ethics Committee, Southern Cross University Ethics Committee (ECN-17-221).
This study will be conducted in multiple sites in NSW and Australia for four years.
NICM chief investigator: Professor Dennis Chang