Clinical trial of Sailuotong (SLT) for Vascular Dementia or Alzheimer’s Disease with evidence of cerebrovascular disease

CONDITION

Neurological

GENDER

Both males and females

AGE GROUP

From 40

and above

STATUS

Active, not recruiting

SLT for Vascular Dementia

Vascular dementia (VaD) is the second major cause of dementia accounting for 15-20 per cent of all dementia cases. VaD is an acquired cognitive impairment due to multiple mini strokes, some of which may be undetectable to the patient. The result is memory loss and a decline in cognitive ability. Currently, viable pharmaceutical options are lacking.

NICM Health Research Institute researchers are looking for people who have a diagnosis of either vascular dementia, or mixed Alzheimer’s and vascular dementia, to take part in our clinical trial. The study investigates whether a standardised Chinese herbal medicine formula, Sailuotong (SLT), can help treat vascular dementia. Results of initial trials show promise in improving memory, learning and daily function.

Eligible participants are now being enrolled in Sydney, Wollongong, Lismore, Melbourne, Brisbane, and Adelaide.

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 (mixed dementia).
  • Participants taking medications for the treatment of dementia, the dose must be stable for at least six 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 eight clinic visits over a 65-week period at one of our trial sites in Sydney, Wollongong, Lismore, Brisbane, Melbourne or Adelaide.

What’s involved?

This clinical trial is a double-blinded study, 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).

Interested in participating?

For further information please visit NICM, phone the trial hotline on (02) 4620 3578 or email dementiatrial@westernsydney.edu.au.

Studies Contact Form

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Approved By: This clinical trial has been approved by the Human Ethics Committees of Western Sydney University (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)              

Clinical Trial Registry Link: Click Here