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 weigh 150 kg (approximately 330 lbs) or less
- People who are willing and able to take part in all parts of the study for its full duration
- People who have adequate vision and hearing, in the investigator's judgment, to complete memory and thinking tests (glasses and hearing aids are allowed)
- People who are considered cognitively and functionally unimpaired as defined by the study's requirements
- People who have a "study partner" available, as defined by the study's requirements (confirm with trial site)
- People whose blood test results for a marker called plasma pTau217 suggest a high likelihood of future changes in thinking or memory
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 who have any condition other than Alzheimer's disease that may affect thinking or memory, such as frontotemporal dementia, Lewy body dementia, vascular dementia, Parkinson's disease, Huntington's disease, or several other specific brain conditions
- People who have mild cognitive impairment (MCI) or any form of dementia
- People with a significant history or current evidence of disease affecting blood flow to the brain
- People with a history of severe brain injury that caused lasting neurological damage or structural brain changes
- People with a history or current presence of a significant growth or mass inside the skull
- People with a history of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
- People who have had a stroke with symptoms in the past 12 months, or a documented episode consistent with a mini-stroke (transient ischemic attack) in the past 12 months
- People who, in the investigator's opinion, may be at risk of suicide
- People who have had a substance use disorder within the 12 months before screening (tobacco use is allowed)
- People with other medical conditions — such as heart, liver, or kidney disease — that are not stable or well-controlled, or that could affect safety or interfere with the study
- People with uncontrolled high blood pressure
- People with significantly reduced liver function
- People with a history or current diagnosis of a significant blood disorder
- People diagnosed with a form of eye disease called wet age-related macular degeneration (AMD)
- People with abnormal thyroid function
- People with abnormally low levels of folic acid or vitamin B12 that are considered clinically significant and/or may affect thinking, in the investigator's judgment
- People with an active HIV, hepatitis B, or hepatitis C infection that has not been adequately treated, in the investigator's opinion
- People with a history of cancer (malignancy)
- People who have previously received an active immunotherapy (vaccine) being studied to prevent or delay cognitive decline
- People who have previously or are currently using a passive immunotherapy (such as immunoglobulin) or other long-acting biologic treatment approved or being studied to prevent or delay cognitive decline
- People who have received any other investigational (experimental) treatment within 5 half-lives of that treatment or 4 months before screening, whichever is the longer period
- People who have received intravenous or injected immunoglobulin therapy within 5 half-lives or 4 months before the study start date, whichever is longer
- People currently taking blood-thinning (anticoagulant) medications, or where there are plans to start such medications during the study
- People taking any medications known as cholinesterase inhibitors (a type of medication sometimes used for memory conditions)
- People who have taken antipsychotic or neuroleptic medications within 3 months of screening, except where used briefly for a non-psychiatric reason
- People who regularly use opiates, opioids, benzodiazepines, barbiturates, sleep medications, antidepressants, or anti-anxiety medications unless they have been on a stable dose for at least 8 weeks before the study start
- People currently enrolled in another interventional study involving an experimental treatment or any medical research that could interfere with this study's thinking and memory assessments
- People currently living in a skilled nursing facility, convalescent home, or long-term care facility
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
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Phone: 1-888-662-6728
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
Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0
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.