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.
- People who:
- Are diagnosed with mild to moderate vascular dementia or Alzheimer's disease with cerebrovascular disease.
- Ability to read and understand English
- Willing to travel and attend eight clinic visits.
Please note, you are eligible to participate in this study if you are taking any pharmaceutical medications that can enhance neurocognition, have been on this medication for more than six months and have achieved a stable dose.
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.
Interested in participating?
For further information please phone the trial hotline on (02) 4620 3578 or email email@example.com.
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 (14/094) and the NSW Guardianship Tribunal (Approval Number: 1/2015). This study will be conducted in multiple sites in NSW and Australia for four years.