Phase 3 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 who have previously taken part in an Alzheimer's clinical trial using the drug buntanetap.
- People who have a study partner who can give written consent to participate, spends at least 10 hours per week with the participant, and can attend study visits at required times.
- Female participants who could become pregnant must have a negative urine pregnancy test at screening, must not be breastfeeding, and must agree to use a highly effective form of contraception.
- Male participants must be sterile, sexually inactive, or agree not to father a child during the study and for one month after the last dose, and must agree to use a barrier method of contraception; female partners of male participants must also use a highly effective method of contraception.
- Thinking and day-to-day functioning must be sufficiently preserved for the participant to give written consent, though a legal representative may provide consent for participants with lower cognitive scores at screening.
- No signs of current suicidal thoughts or a suicide attempt in the past month, as assessed using a standard rating scale.
- Any medications that are allowed during the study must have been taken at a stable dose for at least 4 weeks before screening.
- Sufficient vision and hearing ability to complete all study assessments.
- Generally good health, with no condition expected to interfere with 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 with a history of psychiatric conditions such as schizophrenia, bipolar disorder, or major depression, unless their condition is stable on treatment (mild or historical depression that is stable on an SSRI or SNRI at a stable dose is generally permitted).
- People with a form of dementia other than Alzheimer's disease, such as vascular dementia, Lewy body dementia, frontotemporal dementia, Parkinson's disease dementia, or dementia caused by vitamin B12 or thyroid problems.
- People with a history of seizures, unless their condition is stable on medication.
- Participants from the ANVS-25001 study whose brain MRI shows significant abnormalities, including prior bleeding, certain types of stroke or infarct, brain injury, aneurysm, abnormal blood vessels, fluid on the brain, or a growth such as a brain tumour, unless it is documented and stable (confirm with trial site for specific thresholds).
- Participants from studies other than ANVS-25001 are encouraged to submit a historical MRI taken within the last year for review by the principal investigator; a new screening MRI is not required for these participants.
- People with a history or current evidence of a heart condition affecting the electrical rhythm of the heart, including long QT syndrome or a specific type of dangerous heart rhythm called torsades de pointes, or certain abnormal heart rhythm measurements on an ECG.
- People with a heart rate that is too slow (below 50 beats per minute) or too fast (above 100 beats per minute) on their ECG at screening.
- People with uncontrolled Type 1 or Type 2 diabetes (those with blood sugar control levels up to a certain threshold may be considered if the investigator believes their diabetes is adequately managed).
- People with significantly reduced kidney function or significant liver impairment, based on specific blood test results (confirm with trial site for exact values).
- People with significantly abnormal blood test results, including liver enzyme levels more than twice the upper limit of normal.
- People considered to be at immediate risk of harming themselves or others, or who have reported suicidal thoughts with intent or a plan in the past 2 months, or suicidal behaviour in the past 6 months.
- People who have had cancer or a malignant tumour within the past year, unless they received potentially curative treatment with no signs of return (people with stable untreated cancer are not automatically excluded — confirm with trial site).
- People with a moderate to severe alcohol or substance use disorder in the last 5 years.
- People who have participated in another clinical trial and taken at least one dose of an investigational drug within 4 weeks before screening starts, or within five half-lives of that drug, whichever is longer (unless confirmed to have received only placebo).
- People with a learning disability or developmental delay.
- People whom the site's principal investigator considers otherwise ineligible.
- People with a known allergy to the investigational drug or any of its components, including: silicified microcrystalline cellulose, dibasic calcium phosphate dihydrate, mannitol, stearic acid, hypromellose (used in the capsule shell), or titanium dioxide (used to colour the capsule shell).
- People who are currently pregnant, breastfeeding, or lactating.
- People with uncontrolled high blood pressure (systolic above 160 mmHg and/or diastolic above 95 mmHg) or low blood pressure (systolic below 90 mmHg and/or diastolic below 60 mmHg) that the principal investigator considers medically significant.
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
- Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
- headspace — mental health support for 12 to 25 year olds: headspace.org.au
- 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: 484-875-3192
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
Primary endpoints
Safety of buntanetap; Adverse Events (AE); Treatment Emergent Adverse Events (TEAE); Serious Adverse Events (SAE)
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.