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Trial registered on ANZCTR


Registration number
ACTRN12624000747527
Ethics application status
Approved
Date submitted
30/05/2024
Date registered
17/06/2024
Date last updated
13/10/2024
Date data sharing statement initially provided
17/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Study to Examine the Safety, Tolerability, and Efficacy of KNX100 in the Treatment of Subjects with Agitation Associated with Dementia
Scientific title
KTX-201: A Multi-centre, Phase 2a, Double-blind, Placebo-controlled, Randomised Study to Examine the Safety, Tolerability, and Efficacy of KNX100 in the Treatment of Subjects with Agitation Associated with Dementia
Secondary ID [1] 312203 0
Nil known
Universal Trial Number (UTN)
U1111-1308-6732
Trial acronym
CARES-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation in dementia 333970 0
Condition category
Condition code
Mental Health 330635 330635 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigational Product: Drug- KNX100
Investigational Product: Placebo

Experimental: KNX100 30mg/Placebo- administered orally twice daily for 4 weeks
Adherence will be measured by reviewing daily diary of participants and by drug accountability activities at the site.
Intervention code [1] 328707 0
Treatment: Drugs
Comparator / control treatment
Placebo: Microcrystalline cellulose (Avicel®)
Control group
Placebo

Outcomes
Primary outcome [1] 338381 0
Effect of BID dosing of KNX100, compared with placebo, on Agitation in subjects with dementia.
Timepoint [1] 338381 0
Change in total score from Baseline to Week 4, measured at baseline and at W2 and at W4 post dose during the clinic visit. Week 4 being a primary timepoint.
Secondary outcome [1] 435699 0
Effect of BID dosing of KNX100, compared with placebo, on behavioral changes in subjects with dementia.
Timepoint [1] 435699 0
Mean change from Baseline to Week 4, measured at Baseline and at W4 post dose.
Secondary outcome [2] 435701 0
Effect of BID dosing of KNX100, compared to placebo on caregiver burden.
Timepoint [2] 435701 0
Mean change from Baseline to Week 4 measured at baseline and at W2 and W4 post dose.
Secondary outcome [3] 435702 0
Safety and tolerability of BID dosing of KNX100
Timepoint [3] 435702 0
Adverse Events/Serious Adverse Event reports up to End Of Treatment reviewed by daily diary and measured at every clinical visit (baseline, Week 2, Week 4 and Week 6 (End of Study/End of Treatment) as well as measured by change in physical/neurological parameters from Baseline to End Of Treatment visit.

Eligibility
Key inclusion criteria
1. Mini-mental state examination (MMSE) score of 10 to 24 (inclusive) at the screening visit
2. Current diagnosis of dementia (Alzheimer’s disease, Frontotemporal dementia, Lewy body dementia, multi-infarct dementia or vascular dementia) according to the criteria of the DSM 5 TR.
3. Clinically significant agitation meeting the International Psychogeriatric Association Provisional Criteria for Agitation in Cognitive Impairment. Has clinically significant agitation/aggression as assessed using the NPI-12
4. Live at home and have a consenting caregiver/study partner
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have medical history of distressing psychotic symptoms (delusion and/or hallucinations) that required psychiatric hospitalisation
2. Have a clinically significant medical condition, psychiatric or neurological disease (other than the allowable study dementias), or other brain disorders
3. malignancy within the past 5 years, clinically significant systemic illness, infection or other significant abnormalities as determined by the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by Invoice Web Response System.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/08/2024
Actual
19/08/2024
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 316579 0
Commercial sector/Industry
Name [1] 316579 0
Kinoxis Therapeutics Pty Ltd
Country [1] 316579 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Kinoxis Therapeutics Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 318759 0
None
Name [1] 318759 0
Address [1] 318759 0
Country [1] 318759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315364 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 315364 0
https://bellberry.com.au/
Ethics committee country [1] 315364 0
Australia
Date submitted for ethics approval [1] 315364 0
01/05/2024
Approval date [1] 315364 0
17/06/2024
Ethics approval number [1] 315364 0
Ethics committee name [2] 315417 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 315417 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [2] 315417 0
Australia
Date submitted for ethics approval [2] 315417 0
27/05/2024
Approval date [2] 315417 0
19/08/2024
Ethics approval number [2] 315417 0

Summary
Brief summary
This is a Phase 2, randomised, double-blind, placebo-controlled study assessing the safety, tolerability, and efficacy of KNX100 in out-patients participants with clinically significant agitation/aggression associated with dementia.
The primary objective is to evaluate the effect of twice daily oral dosing of KNX100 for 4 weeks, compared to placebo, on symptoms of agitation in subjects with dementia as measured by Cohen-Mansfield Agitation Inventory.
The secondary objectives of the study include evaluation of the effects of KNX100 on NPI-12 and CGI(S/I) as well as evaluation of caregiver burden by CSI. Safety and tolerability of KNX100 will be also assessed.
Upon meeting eligibility criteria participants will receive blinded treatment twice daily for 4 weeks followed up by 2 weeks of follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134474 0
Dr Peter de Wet
Address 134474 0
University of Sunshine Coast, Clinical Trials, Vitality Village, Tenancy 103, 5 Discovery Drive, Britnya QLD 4574
Country 134474 0
Australia
Phone 134474 0
+61 7 5456 3872
Fax 134474 0
Email 134474 0
[email protected]
Contact person for public queries
Name 134475 0
Tiina Ahveninen
Address 134475 0
Kinoxis Therapeutics, Suite 201, 697 Burke Road, Camberwell, VIC 3124
Country 134475 0
Australia
Phone 134475 0
+61 1800460409
Fax 134475 0
Email 134475 0
[email protected]
Contact person for scientific queries
Name 134476 0
Tiina Ahveninen
Address 134476 0
Kinoxis Therapeutics, Suite 201, 697 Burke Road, Camberwell, VIC 3124
Country 134476 0
Australia
Phone 134476 0
+61 1800460409
Fax 134476 0
Email 134476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.