Phase 2 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
- Adults aged 55 to 85 years old at the time of signing the consent form.
- People who have been diagnosed with Mild Cognitive Impairment (MCI) or mild Alzheimer's disease, based on the NIA-AA 2024 diagnostic guidelines.
- People whose score on the CDR Global Scale (a standard measure of dementia severity) falls between 0.5 and 1.0 at the screening visit.
- People who score 20 or higher on the MMSE (a standard memory and thinking test) at the screening visit.
- People whose brain scan (amyloid PET scan) shows the presence of amyloid, a protein associated with Alzheimer's disease.
- People who are able to understand the information given to them and can sign a consent form voluntarily.
- People who completed the 26-week visit in the main part of this study.
- People who have given written consent to take part in this extension part of the study.
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 memory or thinking problems are caused by something other than Alzheimer's disease, such as stroke, Parkinson's disease, Lewy body disease, or vascular dementia.
- People who have had a stroke, brain bleed, or mini-stroke (transient ischemic attack) in the past 6 months.
- People who have had a heart attack or unstable chest pain (unstable angina) in the past 6 months.
- People with a moderate level of heart failure (classified as New York Heart Association Class II).
- People with a certain type of irregular heart rhythm detected on an ECG, or other clinically significant heart trace abnormalities (confirm with trial site).
- People who have or have had a malignant (cancerous) tumour.
- People with medical conditions that can affect memory and thinking, such as an underactive thyroid, or deficiencies in vitamin B12, folate, or niacin.
- People who have had an alcohol-related disorder within the past 6 months.
- People who test positive for HIV at the screening visit.
- People who test positive for hepatitis B or hepatitis C at the screening visit.
- People who have an active bacterial infection and have taken antibiotics within 7 days before the screening visit.
- People who have had an allergic or sensitivity reaction to any ingredient in the study drug.
- People who have been hospitalised or treated for suicidal behaviour within the past 5 years, or whose responses to a standard questionnaire at screening indicate serious thoughts of suicide or suicidal behaviour.
- People who have received an Alzheimer's disease treatment (such as Lecanemab) within the 6 months before screening.
- People who are expected to need a long-acting benzodiazepine (a type of sedative medication) for sleep problems at the time of screening.
- People whose blood test at screening shows kidney function below an acceptable level (specifically, serum creatinine more than 1.5 times the upper limit of normal, or eGFR below 40 mL/min/1.73 m²).
- People whose blood test at screening shows liver function above an acceptable level (specifically, AST or ALT more than 3 times the upper limit of normal, or total bilirubin more than 2 times the upper limit of normal).
- Women who test positive for pregnancy at screening.
- Women or men who could become pregnant and are planning a pregnancy, or who do not agree to use an accepted form of contraception during the study and for 4 weeks after the study drug ends (accepted methods include complete abstinence, certain hormonal contraceptives, or surgical sterilisation; note that methods such as tracking ovulation timing or withdrawal are not considered acceptable).
- Women who are pregnant or breastfeeding.
- People who have taken part in another clinical trial and received a study drug within 4 weeks before screening.
- People who the study doctor considers unsuitable for the trial for any other reason.
- People who dropped out of the main part of this study.
- People who the study doctor considers unsuitable for the extension part of the study.
- People whose blood test at the baseline visit (start of the extension study) shows kidney or liver function outside acceptable levels, using the same measures described above.
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.
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Trial details
Where this trial is recruiting
Primary endpoints
Safety: Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.