Phase 1 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
- Men or women who have gone through menopause, aged between 50 and 75 years.
- People who have been diagnosed with probable Alzheimer's disease dementia based on established 2011 diagnostic guidelines.
- People whose Alzheimer's symptoms began at age 65 or younger.
- People who score between 5 and 20 on a specific cognitive screening test called the CMMS.
- People who have been on a stable dose of any memory-support or psychiatric medications for at least 2 months before joining the trial.
- People who completed at least primary school education and are able to participate in the cognitive tests required by the study.
- People who score 4 or below on a scale that measures stroke-related causes of memory problems (called the Hachinski Ischemic Score).
- People who score 10 or below on a depression screening questionnaire (called the GDS-30).
- People whose brain MRI scan (including specialised imaging sequences) does not show significant blood vessel-related problems or major brain abnormalities that would be inconsistent with Alzheimer's disease.
- People who have confirmed Alzheimer's-related protein build-up (amyloid) in the brain, shown by a type of brain scan called an amyloid PET scan, done at or before the screening stage.
- People who have adequate vision and hearing to complete the study assessments.
- People who have a reliable caregiver who is able to attend study visits with them and provide information for assessments.
- People who are willing to take part and have signed an informed consent form.
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 dementia is caused by something other than Alzheimer's disease.
- People whose brain MRI shows certain abnormalities, such as significant white matter damage (Fazekas score above 2), more than 2 small stroke-related lesions larger than 1.5 cm, small strokes in critical brain regions (such as the thalamus, hippocampus, or nearby areas), or other serious findings such as brain bleeds, blood clots around the brain, aneurysms, abnormal blood vessels, tumours, or other major structural problems.
- People who have a known allergy to stem cell-derived exosomes or to the PET scan procedure.
- People with a serious psychiatric disorder or severe psychiatric symptoms.
- People with significant active physical health conditions, including severe heart disease, serious widespread infection, or severe liver or kidney problems.
- People with elevated cancer markers in their blood or a history of cancer.
- People with a disease affecting the immune system.
- People with a significant blockage or obstruction in the nasal passages.
- People considered to be at serious risk of suicide.
- People who have taken part in another clinical trial or received stem cell therapy within the past 6 months.
- People who have any other condition that the trial investigator considers makes participation inappropriate.
- People who cannot have an MRI scan, including those with certain metal implants, stents, plates, or pacemakers that are not MRI-compatible, or those with severe claustrophobia.
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: 18017311249
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of Participants With Treatment-Related Adverse Events; Number of Participants With Treatment-Related Clinical Laboratory Abnormalities
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.