Printed from Voxsanity (voxsanity.com.au) — NCT06964230 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Alzheimer's Disease Trial, Not Yet Recruiting
NCT06964230
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 50 to 90 years old at the time of signing the consent form.
- The person joining the trial (or their legal representative) and their caregiver must both sign a consent form agreeing to take part.
- There must be a caregiver — an identified adult who knows the person well enough to report on their thinking, daily functioning, behaviour, safety, and whether they are following the study plan; ideally, this same caregiver would stay involved for the whole trial.
- A blood test must show biological signs of Alzheimer's disease (specifically a marker called %p-tau217), assessed according to recognised Alzheimer's research guidelines at the screening visit.
- A doctor must have clinically diagnosed the person with mild to moderate Alzheimer's disease (Stage 4 or 5) according to recognised Alzheimer's research guidelines at the screening visit.
- Scores on a standard memory and thinking test (called the MMSE) must fall between 14 and 26 at the screening visit.
- A score of less than 4 on a test called the Modified Hachinski scale, which helps distinguish Alzheimer's from other causes of memory problems, at the screening visit.
- A score of between 0.5 and 2.0 on a standard dementia rating scale (called the Clinical Dementia Rating) at the screening visit.
- Vision and hearing must be good enough to complete thinking and memory tests.
- Overall health must be considered stable for the study, based on a review of medical records, a full physical exam, a neurological exam, and blood tests.
- Any ongoing medications must have been taken at a stable dose, or stopped for a required period of time, as set out in the trial's medication rules.
- Must be able to swallow tablets or capsules.
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 currently experiencing an active episode of a significant mental health condition (such as major depression or an anxiety disorder), or who have a current or past diagnosis of schizophrenia or bipolar disorder, or who currently show signs of suicidal thinking or have a history of a suicide attempt.
- People with untreated depression at the screening visit, indicated by a score greater than 9 on a short depression questionnaire (the Geriatric Depression Scale).
- People whose brain MRI scan shows significant changes that could suggest a type of dementia other than Alzheimer's disease.
- People whose brain MRI scan shows other significant findings, such as more than 4 small bleeds, any single large bleed, areas of certain types of bleeding on the brain's surface, fluid build-up, brain injury, abnormal blood vessels, infection, signs of multiple small strokes or major stroke, large vessel disease, severe changes to the brain's white matter, growths in the brain, or brain tumours (though certain small, non-harmful cysts or coverings of the brain under 1 cm may not automatically exclude someone — confirm with trial site).
- People who have been diagnosed with a neurological condition other than Alzheimer's disease that has caused or could cause thinking or memory problems, including any of the following:
- A history of a significant stroke or multiple strokes, confirmed by history or brain scans, or mini-strokes (TIAs) within the 12 months before the start of the trial.
- A history of a serious brain infection.
- A history of, or current, a growth or mass in the brain.
- A history of a significant concussion or repeated head injuries linked to lasting thinking problems in the last 5 years.
- Huntington's Disease.
- Parkinson's Disease.
- A type of dementia that is mainly caused by something other than Alzheimer's (such as vascular dementia, frontotemporal dementia, Parkinson's dementia, or dementia caused by substance use).
- Normal pressure hydrocephalus (a condition involving fluid build-up in the brain).
- A history of seizures (other than childhood febrile seizures) or epilepsy.
- People with a blood sugar control measure (HbA1c) of 10 or above at the screening visit.
- People with a diagnosis of unstable diabetes.
- People with a significant thyroid problem at screening, shown by certain abnormal thyroid blood test results.
- People with signs of liver or kidney problems, including any of the following findings at the screening visit:
- Certain liver enzyme levels (ALT and/or AST) at more than twice the accepted upper normal range.
- A blood bilirubin level above 2 mg/dL.
- A blood creatinine level above 1.5 mg/dL in men or above 1.4 mg/dL in women.
- A urine test result suggesting kidney impairment.
- A kidney function measurement (eGFR) below 50 mL/min/1.73m².
- A liver enzyme (GGT) at more than twice the accepted upper normal range.
- People who test positive for hepatitis B or hepatitis C at the screening visit.
- People with a history of moderate or severe heart failure (classified as NYHA Class III or IV) within the 12 months before the start of the trial.
- People who have had a heart attack, heart bypass surgery, or a certain heart procedure (PTCA) within the 6 months before the start of the trial.
- People whose blood pressure reading at screening is above 160/100 mmHg, or who show a significant drop in blood pressure when standing up, or who experience near-fainting when standing (though the trial investigator may use their judgement in some cases — confirm with trial site).
- People with a significant unstable medical illness, including but not limited to liver, kidney, heart, lung, digestive, hormonal, joint, immune, infection-related, skin, or metabolic conditions.
- People with a history of HIV infection.
- People with a history of marijuana misuse or dependence (other than topical CBD products) within 1 year of the screening visit.
- People with a history of alcohol or drug misuse or dependence (other than nicotine) within 2 years of the screening visit.
- People with a history of cancer within the 5 years before the screening visit (except certain skin cancers, stable prostate cancer not needing treatment, or early-stage cervical cancer in place).
- People with a surgical or medical condition that could significantly affect how a drug is absorbed by the body, including a history of major gastrointestinal surgery (such as bariatric surgery) or a currently active inflammatory bowel condition.
- Women who are pregnant, breastfeeding, or of childbearing potential and not using effective contraception.
- People who are required to take medications that are not permitted under the trial's medication rules.
- People with a known or suspected allergy or sensitivity to the study drug or any of its ingredients.
- People who live in a hospital or in a facility providing moderate to high levels of ongoing care.
- People whose overall health, in the investigator's opinion, could affect the trial results or pose a safety risk.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
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
Principal Investigator: John Didsbury, Chief Executive Officer, Ph.D, T3D Therapeutics, Inc.
Phone: 919-622-3409
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
Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
T3D Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
26 October 2026
Est. completion
1 April 2031
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Change from baseline to end of treatment in ADAS-Cog13 and ADCS-iADL
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.