Phase 1 Alzheimer's Disease Trial, 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 aged between 50 and 85 years old (inclusive), either male or female.
- People who are able to think clearly enough to complete study tasks, can see and hear well enough to participate, and can read and speak the language used in the study (for example, having completed at least six years of schooling, or having worked, or having an equivalent level of knowledge).
- People who have been diagnosed with mild cognitive impairment (MCI) or mild dementia thought to be caused by Alzheimer's disease, based on specific research guidelines (called NIA-AA criteria).
- People who score between 15 and 30 (inclusive) on a standard memory and thinking test called the Mini Mental State Exam (MMSE).
- People who score between 0.5 and 2 on a standard dementia rating scale called the Clinical Dementia Rating (CDR).
- People whose spinal fluid test (cerebrospinal fluid) shows a specific ratio of certain proteins linked to Alzheimer's disease (pTau/Aβ42 ratio greater than 0.024) (confirm with trial site).
- People who have a suitable study partner — someone who can see, hear, and read well enough to take part, speaks the language used in the study, is willing to join the study themselves, and is able and willing to accompany the participant to visits that require a study partner's input.
- People already taking Alzheimer's medications called cholinesterase inhibitors or memantine may still be eligible, provided the dose has been stable for at least 60 days before the study starts.
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 a current medical or neurological condition that could affect thinking or performance on cognitive tests — for example, Huntington's disease, Parkinson's disease, syphilis, schizophrenia, bipolar disorder, currently active major depression, ADHD, multiple sclerosis, ALS, active seizure disorder, current or recent (within the last two years) alcohol or drug abuse or dependence, or a history of serious traumatic brain injury involving loss of consciousness with ongoing neurological effects or skull fracture.
- People whose brain MRI scan shows findings unrelated to Alzheimer's disease that, in the investigator's opinion, could be a leading cause of future cognitive decline, could pose a safety risk, or could make it harder to monitor safety on MRI scans.
- People who, in the past six months, have had serious thoughts about suicide (specifically answering "yes" to items four or five of a standard suicide assessment scale called the Columbia Suicide Severity Rating Scale), or who have engaged in suicidal behaviour (other than non-suicidal self-injury) in the past two years before screening.
- People who have recently taken another experimental drug or treatment, unless enough time has passed for the drug to clear from the body — the required waiting period depends on the type of drug and will be assessed by the trial site.
- People who, in approximately the four weeks before being assigned to a treatment group, have used any drug or treatment known to potentially cause serious harm to major organs — examples include clozapine, certain cancer treatments such as tamoxifen, or immune-suppressing drugs such as methotrexate, interferon, or certain biological medicines used for rheumatic diseases or multiple sclerosis.
- People who test positive for drug use on a screening drug test, where the investigator believes this reflects drug abuse or dependence.
- People with significant heart rhythm or electrical problems on an ECG (heart tracing) that the investigator considers clinically significant — for example, a dangerous type of rapid heartbeat, significant heart conduction blocks without a pacemaker, or a prolonged QT interval on the ECG.
- People for whom a lumbar puncture (spinal tap) would not be safe — for example, those taking blood-thinning medications, those with a low platelet count, those who have had certain back surgeries (other than single-level microdiscectomy or laminectomy), those showing signs of raised pressure in the skull, or those with spinal conditions that would make a lumbar puncture unsafe in the investigator's judgement.
- People with a current or past history of hepatitis or HIV infection, based on a positive blood test result taken during screening.
- People with severely reduced kidney function.
- People with severely reduced liver function.
- People with significant heart disease, including a heart attack, heart failure, or unstable chest pain (angina) within the past six months.
- People who are currently pregnant or breastfeeding.
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: Meghan Riddle, MD, Butler Hospital
Phone: (401) 455-6403
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo group
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.