The clinical trial of SLT for vascular dementia is a multicentre study to evaluate the effectiveness and safety of a standardised herbal medicine formula in patients with vascular dementia and Alzheimer's disease with cerebrovascular disease (mixed dementia).
This clinical trial has been approved by the Human Ethics Committees of Western Sydney University (Approval Number: H10933), South Western Sydney Local Health District Human
Research Ethics Committee (14/06) and the NSW Guardianship Tribunal (Approval Number: 1/2015). This study will be conducted in multiple sites in NSW and Australia for four years.
Purpose of the trial:
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. 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.
What does participation in this research involve?
This clinical trial is a double-blinded study, meaning that participants and their study doctors will not know which treatment is being received. However in certain circumstances the participant's study doctor can find out which treatment the participant is receiving.
Participants will be asked to attend eight scheduled clinic visits and have one scheduled telephone call over a 65 week period. 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.
At each visit, participants will be carefully assessed by the research team, have blood tests, and will be asked to complete several questionnaires. Participants will be reimbursed for their travel expenses to clinic visits.
To be eligible for the trial, participants need to:
- Be over 40 years old
- Be diagnosed with vascular dementia or Alzheimer's disease with cerebrovascular disease.
- Not previously taken any pharmaceutical medications that can enhance neurocognition.
- Willing to travel and attend
For further information please phone the trial hotline on (02) 4620 3578 or email firstname.lastname@example.org