Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called BI 409306 in three groups of people: those with Alzheimer's disease, those with schizophrenia, and healthy volunteers. Each group was split into two smaller groups receiving either a 25 mg or 100 mg dose of the drug. In total, 61 people started the trial and 59 completed it — one participant in the 100 mg Alzheimer's group and one in the 100 mg healthy volunteer group did not finish. The primary thing the trial measured was the percentage of participants in each group who experienced unwanted events specifically related to the eyes during the study. The reported data shows that eye-related events were recorded in 40% of participants taking the 25 mg dose in the Alzheimer's group, 27.3% in the 100 mg Alzheimer's group, 0% in the 25 mg schizophrenia group, 20% in the 100 mg schizophrenia group, 22.2% in the 25 mg healthy volunteer group, and 72.7% in the 100 mg healthy volunteer group. The trial also recorded the percentage of participants who experienced unwanted events that the investigators considered related to the drug — these ranged from 0% in the 25 mg schizophrenia group up to 81.8% in the 100 mg healthy volunteer group across all six groups. The reported data also shows measurements of how much of the drug was present in participants' blood and how quickly it reached its peak level. Peak blood concentrations ranged from 202 to 2,290 nanomoles per litre depending on the group and dose, and the time it took to reach that peak ranged from approximately 0.5 to 1 hour across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Alzheimer's Disease Trial, Completed
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
For people with schizophrenia:
- People aged 18 to 55 who have been formally diagnosed with schizophrenia according to standard diagnostic criteria (DSM-5).
- People whose schizophrenia has been in a stable, non-acute phase for at least 8 weeks before joining the trial.
- People who have been taking a second-generation (atypical) antipsychotic medication — not including Clozapine — at a stable dose for at least 8 weeks, OR a first-generation (typical) antipsychotic at a stable dose for at least 6 months, and whose other psychiatric medications have also been stable for the required time periods.
- People whose symptoms of hallucinations, delusions, and disorganised thinking are rated no more than moderate in severity on a standard clinical scale (PANSS scores at or below 4 for those items).
- People with only minimal movement side effects from their medication and no more than moderate depressive symptoms, as measured by standard clinical rating scales.
For people with Alzheimer's disease:
- People aged 55 to 85 (or older than 85 if the trial doctor considers their general health acceptable) who have been diagnosed with mild Alzheimer's disease according to standard diagnostic guidelines (DSM-5 and National Institute on Aging–Alzheimer's Association criteria).
- People with a score of 18 to 26 on the Mini-Mental State Examination, a standard memory and thinking test.
- People who have either not taken common Alzheimer's medications (such as donepezil, galantamine, rivastigmine, or memantine) for at least 3 months, or who have been on a stable dose of those medications for at least 3 months before joining.
- People who have had a brain scan (CT or MRI) within the past year that is consistent with an Alzheimer's disease diagnosis; if no recent scan is available, one will need to be done at screening.
- People who, if needed, are able to bring a caregiver to trial visits.
For healthy volunteers:
- Age-matched healthy volunteers (aged 18 to 85, or older than 85 if the trial doctor considers their general health acceptable) with no relevant medical conditions, enrolled at specific points in the study based on the ages of participants already enrolled.
For all participants:
- People who are able and willing to follow all study procedures reliably.
- People who have signed and dated a written informed consent form before the first visit; if a legal representative is required, that person must also provide written consent.
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 active eye condition — with or without vision problems — in one or both eyes at the time of screening (such as cataracts, macular lesions, amblyopia, active diabetic eye disease, uncontrolled glaucoma, or active eye infection or inflammation).
- People who have planned eye treatments or surgery scheduled during the study period (such as injections into the eye or eye surgery).
- People who are currently using or plan to use corticosteroid (steroid) medications, either as eye drops or taken by mouth or injection.
- People who are currently using or plan to use medications known to be harmful to the retina, lens, or optic nerve.
- People with schizophrenia who are taking more than two antipsychotic medications (including different forms of the same drug).
- People with Alzheimer's disease whose dementia is caused by something other than Alzheimer's disease, based on clinical or test findings.
- People who have a neurological condition other than Alzheimer's disease, such as Lewy body dementia (as a primary diagnosis), Huntington's disease, Parkinson's disease, epilepsy, vascular dementia, stroke, multiple sclerosis, or intellectual disability.
- People who need to regularly take long-acting sleeping tablets or anxiety medications such as diazepam.
- People with Alzheimer's disease who have taken — within the 3 months before joining, or who plan to take during the trial — certain antidepressants (tricyclics or MAOIs), certain antipsychotics with strong anticholinergic effects, anticholinergic medications, or certain herbal and other substances including St. John's Wort, carbamazepine, or Ginkgo extracts.
- People who have a significant history of strokes or bleeding in the brain that is linked to a decline in memory or thinking.
- People who have experienced serious thoughts of suicide in the past 3 months, or any suicidal behaviour (such as an actual or interrupted attempt) in the past 2 years, as assessed by a standard clinical scale.
- People with serious, unstable, or uncontrolled medical conditions affecting the digestive system, liver, kidneys, lungs, heart, immune system, blood, hormones, or metabolism.
- Women who are pregnant, breastfeeding, or who could become pregnant and are not using an acceptable form of contraception.
- Men who are able to father a child and are unwilling to remain abstinent or use adequate contraception during the trial.
- People with a known or newly diagnosed HIV infection.
- People with significant kidney disease (kidney function below a certain threshold, confirmed with the trial site).
- People who weigh less than 50 kg.
- People with signs of liver disease.
- People with a history of certain neurological or psychiatric conditions (such as stroke, seizures of unexplained cause, or a concussion with loss of consciousness).
- People who have had a cancer diagnosis within the past 5 years, except for a specific type of skin cancer called basal cell carcinoma.
- People who have planned surgery under general anaesthetic, or a planned hospital stay, during the study period.
- People with a significant history of drug dependence.
- People with significant, uncompensated hearing loss; hearing aids are not permitted during the trial.
- Additional exclusion criteria may apply (confirm with trial site).
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial
Other options
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.