Clinical Trials
CERE-CALM
Low-Intensity Focused Ultrasound for Alzheimer’s Disease
A research study for adults living with Alzheimer’s disease and behaviour changes, and the people who support them.
ABOUT THE STUDY
What is CERE-CALM?
CERE-CALM is a clinical research study investigating whether a non-invasive investigational device may help reduce behavioural symptoms such as agitation, restlessness and irritability in people living with Alzheimer’s disease.
The study uses a device that delivers low-intensity focused ultrasound to specific areas of the brain involved in behaviour and emotional regulation. Researchers are assessing whether this approach is safe, well tolerated, and whether it may help reduce these kinds of symptoms over time.
The study is being conducted at research sites across Australia and is sponsored by Ceretas Limited.
Important Notice: This is a research study. The device used in this study has not been approved for therapeutic use in Australia. Taking part is completely voluntary and will not affect your usual medical care.
Non-invasive
A device placed on the scalp: no injection, no surgery, no shaving required.
No new medication
Participants can generally continue their existing medications throughout the study.
For both of you
Early-phase research
FOR PARTICIPANTS AND CAREGIVERS
Who may be eligible?
You or the person you support may be eligible to take part if the following apply. A member of the study team will confirm eligibility at a screening visit.
You may be eligible if:
Aged 50 years or older
Diagnosed with probable Alzheimer’s disease by a clinician
Experiencing behavioural symptoms such as agitation, restlessness, irritability or distress
Living at home or in an assisted living facility
Have a regular caregiver or support person who can attend study visits
On stable medications, if applicable (no dose changes in the past 8 weeks)
You may not be eligible if:
You have metal implants in the head, a pacemaker, or other MRI-unsafe devices
You have severe claustrophobia or are unable to tolerate an MRI scan
You have a major neurological condition unrelated to Alzheimer’s disease (such as stroke or seizure disorder)
You are currently participating in another clinical trial
You have recently started or changed dementia or psychoactive medications
Additional eligibility criteria apply. The study team will review all criteria with you before you decide whether to take part.
What to Expect?
Participation lasts up to approximately 15 weeks and includes around 10 clinic visits. Visits are scheduled during business hours, Monday to Friday. The study team will explain in full what each visit involves before you decide whether to take part.
FOR CAREGIVERS AND SUPPORT PERSONS
You and the person you care for can take part together
Caregivers and support persons are an essential part of the study. As well as supporting the person you care for at visits, you will be asked questions on your own experience of caregiving.
What your role involves:
Attending study visits alongside the person you care for
Providing observations about behavioural symptoms you have noticed
Completing questionnaires about your own experience at key assessment visits
The same caregiver or support person should attend the key assessment visits throughout
Costs and Reimbursement
Voluntary participation
Not everyone will be eligible for this study, and that is completely fine. The study team will provide a respectful explanation and, where possible, connect you with relevant support services.
FOR CLINICIANS
Clinical Eligibility and Referral Information
CERE-CALM is enrolling adults with probable Alzheimer’s disease and clinically significant behavioural and psychological symptoms of dementia (BPSD). For the complete protocol, please contact the local site.
KEY INCLUSION CRITERIA:
Mini-Mental State (MMSE) 10-25
Age 50 years or older
Probable Alzheimer’s disease diagnosis per NINCDS-ADRDA
NPI-12 total score ≥12 at screening and baseline and ≥1 core domain FxS ≥4 at Baseline
Outpatient living at home or in assisted living; ambulatory with knowledgeable informant
Live-in caregiver/informant spending ≥10 hrs/week (≥5 days); same caregiver for all NPI and CMAI visits
Stable anti-dementia or psychoactive medications for ≥8 weeks prior to enrolment
Written informed consent from person responsible; participant consent if capacity allows
Ability to comply with study regimen and communicate during procedures
KEY EXCLUSION CRITERIA:
BPSD attributable to acute medical disorder (e.g. active infection, pain)
MRI contraindications: metallic head implants, unsafe devices, or inability to tolerate
Haemorrhages (including microhaemorrhages) on MRI scan
Prior neurosurgical intervention/craniotomy; scalp/skull abnormalities in sonication pathway
Other neurological conditions (or history of): severe TBI, seizure disorder, stroke, tumours, TIA
History of major psychiatric disorders (schizophrenia, bipolar)
Clotting/bleeding disorder (anti-coagulants; anti-platelet therapy such as low-dose aspirin permitted)
Active inflammatory disease or recent significant infection (within 4 weeks)
Participation in other clinical trials within 90 days of screening
Body weight exceeding 135 kg; pregnancy or breast-feeding
Study Sites
Cognivus Research
Parkway San Clinic
Suite 214/172 Fox Valley Rd
Wahroonga NSW 2076
Dr Amir Papan, PhD
0481 130 352
amir.papan@cognivus.com.au
Frequently Asked Questions
How long is the study?
Your individual participation lasts up to approximately 15 weeks from your first screening visit to your final clinic visit. This includes around 10 clinic visits in total, scheduled during business hours, Monday to Friday.
Will I need to shave my head for the device procedure?
No. The device is placed on the scalp and ultrasound gel is applied to the hair and scalp to assist with the procedure. No shaving or hair removal is required.
Can I stay on my current medications?
In most cases, yes. Participants can continue their current medications provided the doses have been stable for at least eight weeks before joining the study. The study doctor will confirm your eligibility at the screening visit.
What is a sham procedure and why does the study use one?
A sham procedure looks and feels identical to the active device procedure. Participants have a 2:1 chance of receiving the active device rather than the sham. This is standard practice in clinical research to ensure results are not influenced by expectations. Neither participants nor caregivers will know which group they are in during the study. The study team will explain this in full before you decide whether to take part.
Does my caregiver need to attend every visit?
The same caregiver or support person should attend the key assessment visits at the start, mid-way through, and at the end of the study. Their input and observations are an important part of the research. For device procedure sessions, we encourage caregiver attendance but the study team can discuss your specific circumstances.
How does the device work?
The study device uses low-intensity focused ultrasound to target specific areas of the brain involved in behaviour and emotional regulation. The device is placed on the scalp during each procedure session — no surgery or injection is involved. This is an investigational device and the study is designed to evaluate whether this approach is safe and whether it may help reduce behavioural symptoms.
What happens if I am not eligible or decide not to take part?
Not everyone who enquires will be eligible, and that is completely fine. If the study is not suitable, the study team will let you know respectfully. Whether or not the study is a fit, the team will provide information about caregiver support resources including Dementia Australia (1800 100 500). Taking part is entirely voluntary and you may withdraw at any time without this affecting your usual care.
Further reading
The study has been approved by an independent Human Research Ethics Committee. Visit the Australian and New Zealand Clinical Trials Registry (ANZCTR) for more information.
ANZCTR link: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12626000738325
HREC Approval: 2026-03-349 04/05/2026
TGA CTN: CT-2026-CTN-02646-1
ANZCTR Registration: ACTRN12626000738325
Sponsor: Ceretas Limited
Protocol Number: CRTS-NM-001
CRO: Mobius Medical Pty Ltd