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Agitation & Aggression in Dementia

Dementia-related Agitation Study

Dementia-related agitation: Take part in a new research study for a potential new treatment for agitation associated with dementia.

This study aims to evaluate the efficacy and safety of a potential new treatment for dementia-related agitation.

Eligibility

Participant must:

  • be 50 – 90 years of age
  • have a current diagnosis of dementia (Alzheimer’s disease, Frontotemporal dementia, Lewy body dementia, multi-infarct dementia or vascular dementia)
  • be 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

Duration

Up to 10 weeks

Location

VIC

SA

NSW

QLD
 

Participants in the research study will receive:

Reimbursement of costs

For out-of-pocket expenses, such as time, travel and parking.

Contribution to 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.

Expert medical monitoring

Receive top-tier medical care and monitoring from experienced healthcare professionals.

To take part in this study, participants will need to meet all the following (other
criteria apply):

  • 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

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 4 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

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

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:

Evrima Help Centre

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

Read on ANZCTR

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