Dementia trial expands as study signals effectiveness of novel treatment for vascular dementia

Published 7 August 2018
Dementia trial brain

Australians aged 40 and over with dementia are encouraged to participate in one of the nation’s largest clinical trials investigating a novel Chinese herbal extract Sailuotong (SLT). Conducted by NICM Health Research Institute (NICM), the Phase III clinical trial has added three new hospital sites across Lismore, Melbourne and Brisbane, with further sites planned for Adelaide and Perth. The site expansion coincides with positive results from an independent clinical trial of SLT published in the recent journal Alzheimer's & Dementia.

Dementia trial pills
Pills used in the dementia trial.

The Chinese study included 325 participants and suggests SLT as an effective treatment for vascular dementia, improving cognition and daily functioning in Chinese patients with mild-to-moderate vascular dementia. The results reported improved functioning in multiple domains, such as memory, orientation, language and executive function after 26 weeks of SLT treatment.

These promising results are highly significant, as current available treatment options for vascular dementia are very limited. If the present Australian clinical trial is successful, SLT will be an effective frontline treatment for thousands of people across the world with vascular dementia.

Eligible patients across the Northern Rivers are now being enlisted for the new hospital and clinic sites in Lismore. Southern Cross University is coordinating the Lismore trial which will be conducted at the University and St Vincent’s Hospital.

“This is a great project and Southern Cross University is very excited to be participating,” said Professor Stephen Myers, Principal Investigator based at Southern Cross University’s NatMed-Research Unit.

“It is tackling one of the significant problems in modern healthcare using herbal medicines that has been standardised and quality assured to pharmaceutical specifications.”

Today in Sydney, Dr Jianping Jia, Professor and Dean of Neurology at Beijing Xuan Wu Hospital and Capital Medical University and the Chief Investigator of the recent Chinese study, will present the results to NICM’s Australian research team consisting of leading dementia researchers, neurologists, geriatricians and aged care professionals.  

Held at NICM’s facilities at the Westmead precinct, the meeting aims to increase engagement and participation in the Australian study and discuss the recent Chinese trial results and potential implications for the Australian trial.

Chief Investigator of the Australian Phase III trial, Professor Dennis Chang, from NICM Health Research Institute at Western Sydney University, said: “the meeting is an opportunity to hear from Professor Jia, one of China’s leading neurologists and researchers in dementia.”

“We will also discuss practical approaches to help study sites and researchers recruit and retain volunteers for our 52-week study. We aim to recruit at least 226 participants by mid next year to ensure robust scientific data and conclusions.”

Eligible patients are also being enlisted for the new hospital and clinic sites at Brisbane’s The Prince Charles Hospital, and The Royal Melbourne Hospital. Recruitment also continues at previous hospital and clinic sites across Sydney, including Bankstown-Lidcombe Hospital, Hornsby Ku-ring-gai Hospital, Liverpool Hospital, Norwest Private Hospital’s Specialist Services Medical Group, Waverley’s War Memorial Hospital, and at Wollongong Hospital and Canberra’s More than Medicine clinic site.

There are currently over 400,000 Australians living with dementia and vascular dementia is the second most common type of dementia after Alzheimer’s disease. Without a medical breakthrough, the number of Australians living with dementia is expected to double over the next two decades.

If you are interested in participating in the clinical trial:

 

MEDIA CONTACT for more information or to arrange an interview

Lismore – Sharlene King, Southern Cross University, 0429 661 349

NICM Health Research Institute - Natalie Connor, +61 417 259 054

 

This trial supports dementia research and innovation and aligns with the World Health Organization’s (WHO) Global action plan on the public health response to dementia 2017-2025; Towards a dementia plan: a WHO guide; the 2030 Agenda for Sustainable Development, in Promoting Health, Sustainable Development Goal 3 (good health and wellbeing); and the Australian Government National Framework for Action on Dementia 2015-2019.

The researchers acknowledge the support of Shineway Pharmaceuticals for this study. This study 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), the NSW Guardianship Tribunal (Approval Number: 1/2015), Specialist Services Medical Group Research and Ethics Committee, Southern Cross University Ethics Committee (ECN-17-221).

 

MEDIA MATERIALS AND BACKGROUND

  • Hi-res images are available on request.
  • Dementia awareness month is fast approaching with the awareness month held every September in Australia.
  • Today’s event will be held at the NICM Health Research Institute’s new facilities at Western Sydney University’s Westmead Campus, at the Westmead health and research precinct.
  • Australia and New Zealand Clinical Trial Registry(ACTRN12616000057482)
  • 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.
  • Study participant criteria:
  • Be over 40 years of age.
  • Be diagnosed with mild-to-moderate vascular dementia or Alzheimer’s disease with cerebrovascular disease.
  • Not taken similar herbal ingredients that can enhance neurocognition.
  • Ability to read and understand English.
  • Sailuotong (SLT) is a complex combination of ginseng, ginkgo and saffron that has been scientifically developed and tested by a combined team from Xiyuan Hospital, China Academy of Chinese Medical Sciences and NICM Health Research Institute at Western Sydney University.
  • Over the last 10 years, Sailuotong has been systematically studied in the laboratory and clinical trials. These preliminary studies have shown Sailuotong improves the cognitive and memory impairment associated with vascular dementia.
  • In recent years, Chinese medicine ingredients have been combined in complex formulations to treat cognitive disorders. Researchers have argued that the reason for the efficacy of modern compound Chinese medicines is that the bioactive components interact synergistically leading to greater pharmacological effects or better clinical outcomes than predicted by the activity of single components.
  • Dementia is not a single specific disease. It is an umbrella term describing a syndrome associated with more than 100 different diseases that are characterised by the impairment of brain functions, including language, memory, perception, personality and cognitive skills.
  • Although dementia mainly affects older people, it is not a normal part of ageing.
  • Alzheimer disease is the most common type of dementia, accounting for about 50% to 75% of dementia cases worldwide.
  • Vascular dementia is generally considered to be the second most common type of dementia, with about 20% to 30% of dementia cases thought to be this type. Vascular dementia, maybe associated with numerous mini strokes, some of which may be undetectable to the patient, hypertension and diabetes. The result is memory loss and a decline in cognitive ability.
  • Worldwide, around 50 million people have dementia, and there are nearly 10 million new cases every year.
  • There is no treatment currently available to cure dementia or to alter its progressive course.
  • The estimated proportion of the general population worldwide aged 60 and over with dementia at a given time is between 5 to 8 per 100 people.
  • The total number of people with dementia worldwide is projected to reach 82 million in 2030 and 152 million in 2050. Much of this increase is attributable to the rising numbers of people with dementia living in low- and middle-income countries.
  • Dementia is now the second leading cause of death in Australia.
  • World Health Organization Fact Sheet - Dementia
  • Towards a dementia plan: a WHO guide
  • Key facts and statistics from Dementia Australia
  • Vascular Cognitive Impairment from Dementia Australia

 

About NICM Health Research Institute

Western Sydney University’s NICM Health Research Institute is Australia’s leader in integrative and complementary medicine research and policy. Seed funded by the Commonwealth and NSW state governments, NICM plays a key national role in ensuring Australians have access to reliable evidence on complementary medicines and treatments in wide use. As an ERA 5 ranking institute, NICM is globally recognised for its world-class research and innovations in integrative and complementary medicine. More information is available at www.nicm.edu.au

Media contact: Sharlene King 0429 661 349 or scumedia@scu.edu.au