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Dementia-Related Agitation Study

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:

  • 50 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
  • Reside at the same location for at least 2 weeks prior to screening and for the study duration
  • Have a caregiver or study partner who is 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

Participants and their caregivers will receive reimbursement for out-of-pocket expenses, such as travel, meals and parking. The study team will be able to provide further information at the first visit. This does not apply to paid professional caregivers in care facilities.

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.

Contribution to research

Help investigate a potential new treatment that could improve the lives of individuals with dementia-related agitation.

Follow the link to above find details about your closest study location

 

Where is your closest location?

Victoria

New South Wales

South Australia

Queensland

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

  • 50 years of age and over
  • Current diagnosis of dementia (Alzheimer’s disease, Frontotemporal dementia, Lewy body dementia, multi-infarct dementia or vascular dementia)
  • Have significant agitation/aggression episodes at least twice per week
  • Reside at the same location for at least 2 weeks prior to screening and for the study duration
  • Have a caregiver or study partner who is available to participate in the study

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

  • Have a history of hospital admission for primary psychiatric condition
  • Severe illness or abnormality that is determined by the study doctor
  • Have a severe medical condition, psychiatric or neurological disease, other than dementia

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 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, 2 visits and a phone call.
  • A final follow up 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.

Please contact your nearest site for additional information.

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

Read on ANZCTR