Study to Examine the Safety, Tolerability, and Efficacy of KNX100 in the Treatment of Subjects with Agitation Associated with Dementia

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000747527

Acronym

CARES-X

Enrollment

Registered

2024-06-17

Start date

2024-08-19

Completion date

2026-10-30

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a Phase 2, randomised, double-blind, placebo-controlled study assessing the safety, tolerability, and efficacy of KNX100 in both out-patients and care facility 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/NPI-NH and CGI(S/I) as well as evaluation of caregiver burden by CSI for community dwelling subjects. 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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to 90 Years

Healthy volunteers

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

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 4 years, clinically significant systemic illness, infection or other significant abnormalities as determined by the investigator

Outcome results