Study information for participants: Investigating a potential new treatment for agitation associated with dementia.
Quick Reference:
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
This study aims to evaluate the effectiveness and safety of a potential new treatment
for dementia-related agitation.
Where is my nearest study site?
Here is a list of all of the sites who are currently recruiting for this study:
VIC
- Austin Health - Melbourne Brain Centre, 245 Burgundy Street, Heidelberg 3084, VIC
- Northeast Health - 35/47 Green St, Wangaratta, 3677, VIC
- Box Hill Hospital - 8 Arnold Street, Box Hill 3128, VIC
SA
- Level 4C, Wayfinding 4C610, Royal Adelaide Hospital, Port Road, Adelaide, South Australia, 5000
NSW
- Hornsby Ku-ring-gai Hospital
Rehabilitation & Aged Care Office (RACS)
Level 4, Building 60, Palmerston Road, Hornsby NSW 2077
Who can participate?
To take part in this study, you will need to meet all the following:
- 50 - 90 years of age
- Current diagnosis of dementia (Alzheimer’s disease, Frontotemporal dementia,
Lewy body dementia, multi-infarct dementia or vascular dementia) - Experiencing agitation/aggression episodes at least twice per week
- Live at-home
- Have a caregiver or study partner who will be available to participate in the study
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- Have medical history of distressing psychotic symptoms (delusion and/or
hallucinations) that required psychiatric hospitalisation - History of stroke within 12 months of screening or any history of haemorrhagic
stroke - Have severe medical condition, psychiatric or neurological disease, other than
dementia - History of cancer within the past 5 years
with our team.
What is involved?
If deemed eligible for the study, participation is expected to last up to 10 weeks. This
includes:
- Visit 1 = Day -28 to -1 screening visit
- Visit 2 = Day 1 baseline clinic visit
- Visit 3 = Day 7 phone call
- Visit 4 = Day 14 clinic visit
- Visit 5 = Day 28 end of treatment visit
- Visit 6 = Day 42 end of study visit
Participation in this research is voluntary and participants may withdraw from the
study at any time.
If you take part in the research study, there will be:
- Reimbursement of costs; For out-of-pocket expenses, such as travel and parking.
- Expert top-tier monitoring; Receive top-tier medical care and monitoring from experienced healthcare professionals.
- Contribution to medical research; Help investigate a potential new treatment that could improve the lives of individuals with dementia-related agitation.
- Free study-related medical care; Be among the first to access potential new research treatments in development.
What is dementia-related agitation?
Dementia encompasses a range of cognitive impairments including memory loss,
language difficulties, and challenges with problem-solving, all of which significantly
interfere with daily life. As the disease gets worse, people with dementia may become
agitated and may be restless or worried. Agitation may cause pacing, sleeplessness,
or aggression.
Why is this study important?
Agitation and aggression affect as many as 76% of people with dementia, impacting
the quality of life for both people with dementia and their caregivers. The findings
from this study could pave the way for improved management of agitation
associated with dementia.
Who is involved?
This study is being sponsored by Kinoxis Therapeutics Pty Ltd, a private, Australian-
based, clinical stage biotechnology company developing first-in-class therapeutics
to address the escalating demand for effective treatments for social dysfunction in
neurological and psychiatric disorders and substance use disorders.
This trial has been approved by an independent ethics committee
Ready to register? Click here to sign up/login to Evrilink and start your clinical trial journey.
Still have questions? Use the form below and one of our patient experience team members will be in touch to assist with your enquiry!