Alzheimer's Disease Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People aged between 50 and 85 years old.
- People who scored 23 or lower on a Korean-language memory and thinking test called the K-MMSE.
- People who had a positive brain scan (called an 18F-Florbetaben PET scan) showing signs of Alzheimer's-related changes.
- People who have been diagnosed with either mild memory and thinking problems (mild cognitive impairment) or dementia caused by Alzheimer's disease, each meeting specific diagnostic standards.
- If the diagnosis is mild cognitive impairment: it must be the memory-affecting type, classified according to Peterson criteria.
- If the diagnosis is Alzheimer's dementia: it must meet the standards set by the National Institute on Aging and the Alzheimer's Association (NIA-AA).
- People already taking Alzheimer's medications (such as donepezil, rivastigmine, galantamine, or memantine) must have been on a stable dose for at least 3 months.
- People who are able to communicate about what they feel during use of the investigational medical device being tested in the trial.
- People who have chosen to take part voluntarily and have signed a written consent form.
- People who are willing to follow the trial's instructions and schedule.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose caregiver has reported significant delusions, hallucinations, or agitation/aggression (scoring 2 or more on a standard caregiver-reported assessment called the CGA-NPI).
- People with a known allergy, sensitivity, or medical reason to avoid the MRI contrast dye gadolinium (Gadovist®) or the ultrasound contrast agent Definity®.
- People who have implanted metal devices or other standard reasons that make MRI scanning unsafe for them.
- People with a known allergy, sensitivity, or medical reason to avoid local anaesthetics or sedation medicines that may be used during the trial procedure.
- People whose MRI results show any of the following brain concerns: severe blood-flow related changes in the brain (a Fazekas score of 3 or more, more than 5 small stroke-related spots, or more than 3 tiny bleeds); active or ongoing infection or inflammation; acute or ongoing bleeding; a tumour or growth taking up space in the brain; enhancement of the brain's lining; or abnormally low pressure around the brain.
- People where 30% or more of the area of the skull that needs to be treated is covered by scars, a scalp condition, or thinning of the scalp.
- People with a history of seizures or epilepsy that could be made worse by opening the blood-brain barrier (a protective layer between the blood and the brain).
- People with a history of bleeding disorders or problems with blood clotting.
- People with a serious heart condition or unstable blood circulation (such as uncontrolled high blood pressure, irregular heartbeat, or angina).
- People with significantly reduced kidney function (a filtration rate below 30 mL/min/1.73m²).
- People whose brain has shrunk too much (severe atrophy) for the device to be targeted accurately.
- People who are HIV positive and are at increased risk of HIV entering the brain.
- People who have a potential blood-borne infection that could spread to the brain and cause meningitis or a brain abscess.
- People who carry two copies of a gene variant called ApoE4, which is associated with a thinner blood-brain barrier.
- People who are pregnant or breastfeeding.
- Women of childbearing potential who are not willing to use an approved method of contraception for the full duration of the trial (confirm with trial site for specific contraception requirements).
- People who are currently in another clinical trial, or who have taken part in another clinical trial within the 90 days before their screening date.
- People whom the trial investigator considers unsuitable for ethical reasons or because their participation could affect the trial's results (specific reasons must be recorded).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Change in standardized uptake value ratio (SUVR) on FBB-PET
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.