Highlights

  • Ceretas has enrolled the first patient in its Phase 2 CERE-CALM clinical trial.
  • The trial tests non-invasive focused ultrasound for behavioural and psychological symptoms of dementia in Alzheimer's patients.
  • The randomised, double-blind, sham-controlled study targets 66 participants.
  • The trial is fully funded, with A$3.4 million of IPO proceeds allocated, and is expected to complete in the first half of CY2028.

Ceretas Limited (ASX:CTS) has enrolled the first patient in its Phase 2 CERE-CALM clinical trial. The study is evaluating the company's non-invasive therapeutic ultrasound platform as a treatment for behavioural and psychological symptoms of dementia (BPSD) in people with Alzheimer's disease.

CERE-CALM Trial Design

CERE-CALM is a randomised, double-blind, sham-controlled Phase 2 study targeting 66 participants, with a minimum of 60. Participants are randomised 2:1 to active treatment or sham and must be adults aged 50 and over with probable Alzheimer's disease and BPSD. Each participant receives six treatments over 12 weeks, comprising four weekly sessions followed by two monthly sessions.

The primary endpoint is the change in Neuropsychiatric Inventory (NPI) total score from baseline to week six. Secondary endpoints include caregiver distress at weeks six and 12, the durability of effect at week 12, and overall safety and tolerability.

Clinical Need and Earlier Results

BPSD affects more than 90% of Alzheimer's patients and is linked to hospitalisation and earlier admission to residential aged care. Alzheimer's is the most common cause of dementia, affecting about 57 million people worldwide. CEO and Managing Director Dr Rachel de las Heras said, "Behavioural and psychological symptoms are among the most challenging aspects of Alzheimer's disease."

A Phase 1 first-in-human study conducted at The University of Queensland's Queensland Brain Institute in 2024 involved 12 Alzheimer's patients. It found the treatment to be fast, safe and well tolerated, with preliminary signals of behavioural improvement. The results were published in Brain Communications in December 2025. Separately, the Queensland Brain Institute is running the Phase 2 AGIFUS trial using the same technology for Alzheimer's-related agitation, funded by Queensland Health.

Trial Sites, Funding and Next Steps

Recruitment is underway at Cognivus Research in Sydney, with St Vincent's Hospital Sydney and the John Hunter Medical Research Institute expected to begin recruiting shortly. The trial is fully funded, with A$3.4 million of IPO proceeds allocated, and is expected to complete in the first half of CY2028.

Ceretas plans to use the results to inform its next stage of clinical development and commercialisation. If the results are positive, the company intends to engage with regulators on approval requirements and design further studies. Work on a next-generation ultrasound device is also continuing.

Key Takeaways

  • First patient enrolment marks the start of Ceretas' Phase 2 CERE-CALM trial.
  • The study targets a significant unmet need, as BPSD affects most Alzheimer's patients.
  • Phase 1 results showed the treatment was safe and well tolerated.
  • The trial is fully funded and expected to complete in the first half of CY2028.