Low-intensity focused ultrasound (LIFU) neuromodulation treatment of the Behavioural and Psychological Symptoms of Dementia (BPSD) associated with Alzheimer’s disease (AD)

The CERE-CALM clinical trial evaluates the safety and efficacy of a non-invasive medical device, the Ceretas Device v1.0, which uses low-intensity focused ultrasound (LIFU) to target brain circuits.

It aims to reduce challenging behavioural and psychological symptoms of dementia—such as agitation, aggression, and excessive motor activity—in individuals diagnosed with mild to moderate Alzheimer’s disease.

By comparing the treatment against a sham control, the study also assesses whether this approach can improve patient cognition and relieve emotional distress for caregivers.

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

• aged at least 50 years
• have a diagnosis of probable mild-to-moderate Alzheimer’s disease and clinically significant behavioural symptoms such as agitation or aggression
• live at home or in assisted living
• have any psychoactive medications stable for at least 8 weeks,
• have a dedicated caregiver who can attend visits and provide consistent contact

Participation involves enrolling in a randomised, double-blind study over a 12-week evaluation period. Outpatient visits include receiving repeated ultrasound sessions, undergoing a baseline brain MRI, wearing a continuous movement sensor to track physical activity and heart rate, and completing periodic cognitive assessments.

The caregiver must actively participate by attending scheduled study visits across the 12 weeks to complete questionnaires regarding the participant's agitation, neuropsychiatric symptoms, and their own caregiver strain.