phase II
enrolling now

The Dementia Agitation Trial

For carers and families supporting adults aged 50–90 living with dementia-related agitation. Conducted at our Birtinya clinic on the Sunshine Coast.
Age 50-90
day visits
Up to $1250
About this trial

Understanding dementia agitation and this clinical trial

Dementia agitation is one of the most distressing and challenging symptoms of dementia. It can manifest as restlessness, verbal outbursts, or aggressive behaviour, and occurs frequently, often multiple times a week. For carers and families, managing these episodes can be exhausting and emotionally demanding, and current treatments don't always provide adequate relief. In Australia alone, 446,500 people are living with dementia.

This dementia agitation clinical trial is evaluating an investigational treatment to assess whether it can reduce the frequency and severity of agitation in people living with dementia, compared to a placebo. Researchers hope the findings will support the development of better, more targeted options for one of dementia's most difficult-to-treat symptoms.
A consenting caregiver or study partner is required to attend all clinic visits in person and assist with daily diary completion. Reimbursement is available for both the participant and their carer for time spent on the trial.
Eligibility

Do you qualify?

Aged 50–90
Diagnosed with dementia and experiencing significant agitation two or more times per week on average
Lives at home
Weighs at least 45kg
Has a consenting caregiver willing and able to attend all study visits and complete a daily diary
Clinically significant medical condition within the past 4 weeks
Have not responded to, or are intolerant to analgesics and/or NSAIDs
Cancer within the past 4 years (exceptions apply, please speak to our recruitment team)
What's involved

Commitment and procedures

Visit type
day visits
total visits
5 + 1 phone call
duration
~10 weeks
treatment
Oral capsule

procedures 

Physical examination
Vital signs monitoring
Medical history review
Blood test
Knee joint examination
X-ray imaging
Questionnaires
Treatment or placebo injection

treatment design

Eligible participants will be randomly assigned to receive either the investigational treatment or a placebo. Participants must be accompanied by their caregiver or study partner at all clinic visits, who will also assist with completing the daily diary throughout the trial. 

All procedures related to the dementia agitation trial will be explained clearly, and participants and their carers can ask questions at any time.
More information

Have questions? We're here to help.

Contact our recruitment team directly, they're happy to answer any questions before you apply. Please do not send personal medical information by email.
Phone
+07 5409 8640
Hours
Mon–Fri, 8am–5pm
Trial at a glance
Status
enrolling
Phase
phase II
Therapeutic Area
Ages
50-90
Duration
~10 weeks
Visits
5 visits, 1 phone call
Location
Birtinya clinic
PROTOCOL
KTX201
Reimbursement
Up to $1250

Ready to check your eligibility?

It takes less than 2 minutes to fill out our dementia agitation trial form.
Apply for this trial →
We won't share your details with third parties.
This trial has been reviewed by an independent human research ethics committee.

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