Low-intensity focused ultrasound neuromodulation treatment of the behavioural and psychological symptoms of Dementia associated with Alzheimer’s disease

CERE:CALM is an early-phase clinical research study investigating whether a non-invasive device using low-intensity focused ultrasound may help reduce behavioural symptoms such as agitation and restlessness in people living with Alzheimer's disease. 

The study enrolls adults aged 50 and over with a diagnosis of probable Alzheimer's disease, each participating alongside a regular caregiver or support person. Conducted across multiple Australian sites and sponsored by Ceretas Pty Ltd, the study assesses not only changes in behavioural symptoms and cognition, but also the experience on caregivers — recognising that these symptoms affect the whole care relationship. 

People who meet the following criteria may be eligible to participate:

• Aged 50 years or older
• Diagnosis of probable Alzheimer's disease from a clinician (NINCDS-ADRDA criteria)
• MMSE score between 10 and 25 (mild to moderate Alzheimer's disease)
• Experiencing clinically significant behavioural symptoms — NPI-12 total score of 12 or above at both screening and baseline, with at least one core domain Frequency × Severity score of 4 or above
• A regular caregiver or support person who can attend study visits (live-in, or at least 10 hours per week contact across at least 5 days per week)
• On stable doses of any anti-dementia or psychoactive medications for at least 8 weeks prior to enrolment
• Able to have MRI

Participation lasts approximately 15 weeks from the first screening visit to the final clinic visit, with around 10 visits in total. Participation involves:

• 2 assessment visits at the start of the study — a screening visit to confirm eligibility, and a baseline visit that includes a full assessment 
• 4 weekly device procedure sessions during the initial treatment phase
• 1 mid-study assessment visit
• Two monthly booster device procedure sessions
• One final assessment visit at the end of the study
   

Participants and their caregivers receive reimbursement for time and travel at each visit.