Unfortunately, if any of the following criteria apply, this study is not the right fit:

• 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 a severe medical condition, psychiatric or neurological disease, other than dementia
• History of cancer within past 5 years of Screening

Please note, additional eligibility criteria apply.

If deemed eligible for the study, participation is expected to last up to 10 weeks. This includes: 

• A screening period of up to 28 days
• A baseline clinic visit where you will be randomised to receive either the investigational treatment or a matching placebo. 
• A 4 week treatment period which will include twice daily dosing at home, 2 clinic visits and a phone call.
• A final follow up clinic visit.

Participation in this research is voluntary, participants may withdraw from the study at any time

This study aims to evaluate the effectiveness and safety of a potential new treatment for dementia-related agitation. This investigational medication may be a new safe and effective treatment for managing agitation in dementia patients, providing hope for improved quality of life for individuals with dementia and their caregivers.

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.

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.

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 substance use disorders and social dysfunction in neurological and psychiatric disorders.

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

Coming soon in 2025:

• Adelaide, SA
• Hornsby, NSW

We're here for you! Click or tap the button below to read the study FAQs or to send an email to our friendly Patient Experience team:

Contact us

This study has been approved by an independent Human Research Ethics Committee

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