Highlights

  • Ceretas enrolled the first patient in CERE-CALM, a Phase 2 study of ultrasound for Alzheimer’s-related behavioural and psychological symptoms.
  • The randomised double-blind study targets 66 participants and compares active treatment with sham across six sessions over twelve weeks.
  • The company allocated A$3.4 million of initial public offering proceeds to the trial and describes the study as fully funded.
  • Ceretas expects completion in the first half of 2028, with efficacy and safety outcomes still unknown at the enrolment stage.

Patient enrolment has begun in Ceretas Limited’s (ASX:CTS) CERE-CALM trial, moving its ultrasound platform into a controlled test of Alzheimer’s-related behavioural symptoms. The 29 October 2026 announcement records the first participant, rather than a clinical result. The company targets 66 participants and expects the Phase 2 study to finish in the first half of 2028.

Sham Comparison Will Test Symptoms

CERE-CALM is randomised, double-blind and sham-controlled. It targets a minimum of 60 participants, with a planned total of 66, aged 50 or older with probable Alzheimer’s disease and behavioural and psychological symptoms of dementia.

Participants are allocated two to one between active ultrasound and sham treatment. The schedule comprises four weekly sessions followed by two monthly sessions, making six sessions over 12 weeks.

The primary endpoint compares change in total Neuropsychiatric Inventory score from baseline to week six between the two groups. Secondary measures assess caregiver distress at weeks six and twelve, durability of any effect at week twelve, and safety and tolerability.

Recruitment is under way at Cognivus Research in Sydney. St Vincent’s Hospital in Sydney and the John Hunter Medical Research Institute are expected to begin recruitment shortly, with multiple Australian sites planned.

Portable Platform Uses Focused Ultrasound

Brisbane-based Ceretas is developing a portable device that directs low-intensity focused ultrasound through the skull. Its technology draws on more than a decade of University of Queensland and Queensland Brain Institute research.

The company describes two mechanisms. Neuromodulation aims to influence circuits involved in memory, cognition and behaviour. Opening the blood-brain barrier may help clear disease-associated proteins and improve delivery of therapeutic agents.

Those proposed mechanisms are distinct from demonstrated treatment benefit in the present trial. No regulatory approval has been sought or granted for the device in this indication.

Behavioural symptoms can include agitation, aggression, anxiety, depression and apathy. Ceretas says they affect more than 90% of people with Alzheimer’s and are associated with hospitalisation and earlier residential aged-care admission.

Earlier Signals Precede Larger Testing

Ceretas points to a 2024 first-in-human study involving 12 people. That study reported tolerability and preliminary behavioural improvement signals, but its size cannot establish efficacy.

The Queensland Brain Institute is separately running a Phase 2 study of the same technology in Alzheimer’s-related agitation, funded independently by Queensland Health. It is distinct from CERE-CALM.

Ceretas has allocated A$3.4 million of IPO proceeds to CERE-CALM and says the trial is fully funded. Work on a next-generation therapeutic ultrasound device continues in parallel.

The current priorities are enrolment and trial execution. Results are intended to inform later clinical development, study design, regulatory engagement and commercialisation strategy. The announcement gives no revenue expectations and does not establish benefit over sham treatment.