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
- The person joining (or their legal representative) must be willing and able to give written consent, attend all study visits, and follow all study requirements.
- Adults between 50 and 90 years of age (inclusive) at the time of screening are eligible.
- People who have been diagnosed with dementia due to Alzheimer's disease (AD), confirmed using recognised medical diagnostic guidelines (DSM-5 and NINCDS-ADRDA criteria).
- People who show agitation linked to Alzheimer's disease, meaning they have cognitive impairment, signs of emotional distress, and certain observable behaviours such as excessive restlessness, verbal aggression, or physical aggression — where these behaviours are not fully explained by another illness or substance use.
- People whose agitation is considered clinically significant, based on scores above a certain threshold on a standard assessment tool (NPI-C Agitation or Aggression score greater than 4).
- People with a cognitive test score (Mini Mental Status Examination) between 8 and 20 (inclusive).
- People who score 60 or above on a standard agitation assessment (Cohen-Mansfield Agitation Inventory) at both the screening and baseline visits, and who also show a minimum level of aggressive behaviour as defined by specific scoring thresholds on that assessment.
- People who are already taking Alzheimer's-specific medication must have been on a stable dose for more than 3 months before starting the study drug.
- People who have at least one study partner — such as a spouse or caregiver who has close regular contact — who can support them at all scheduled study visits and procedures.
- People who do not live in an assisted living facility are eligible, provided they are able to return for study visits.
- People with adequate vision and hearing (with glasses or hearing aids if needed) to read consent documents, respond to verbal instructions, and take part in interviews and cognitive tests, as judged by the investigator.
- People with adequate blood cell counts, kidney function, and liver function, confirmed by laboratory tests before the first dose (confirm with trial site for specific values).
- Female participants must either be past menopause (no periods for 12 months without another medical cause, confirmed by a hormone test) or have had surgical procedures that prevent pregnancy — or, if pregnancy is possible, must have a negative pregnancy test and agree to use adequate contraception and not attempt to become pregnant or donate eggs from consent until at least 30 days after the last dose.
- Male participants must agree not to donate sperm until at least 90 days after the last dose, and must agree to use adequate contraception during sexual activity with a female partner who could become pregnant, from the time of consent until at least 90 days after the last dose; specific condom requirements also apply when a partner cannot become pregnant (confirm with trial site for details).
- People with suitable veins for blood sample collection.
- People who are willing and able to follow all study assessments and the study schedule.
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 known allergy to the study drug or any of its ingredients.
- People with a history of severe allergic reactions (such as anaphylaxis) or other significant allergies that, in the investigator's opinion, would interfere with participation.
- People with a history of, or currently have, a clinically significant and unstable (not well controlled by medication) condition affecting the heart, lungs, liver, kidneys, blood, digestive system, hormones, immune system, skin, mental health, or nervous system, within the past 3 months, that the investigator considers relevant.
- People with a history of repeated falls (two or more falls within 6 months before screening) that resulted in injury, were linked to illness, loss of consciousness, or abnormal vital signs — or a fall resulting in a fracture within 12 months before screening.
- People who have had surgery or been hospitalised within 3 months before screening, or who have surgery planned during the study.
- People with a history of cancer (malignant disease) within the past 5 years, with the exception of certain types of surgically removed skin cancers.
- People with a history of a clinically significant brain or nervous system event or diagnosis in the past 5 years, including but not limited to epilepsy, significant brain injury, brain surgery, neurosyphilis, meningitis, or encephalitis.
- People who are experiencing delirium at the time of their baseline assessment, as determined by standard diagnostic tools.
- People who have started medications that affect the brain or nervous system (including but not limited to cannabinoids, benzodiazepines, antidepressants, and antipsychotics) within 4 weeks before the first dose of the study drug.
- People with a history of major psychiatric disorders in the past 5 years, including but not limited to psychosis and bipolar disorder (mild and well-controlled psychiatric conditions may be considered on a case-by-case basis in discussion with the study sponsor).
- People who have a known history of, or test positive for, HIV, hepatitis B, or hepatitis C at the screening visit (a negative hepatitis C RNA result may be acceptable — confirm with trial site).
- People currently taking certain medications that could interact significantly with the study drug, including strong CYP3A4 or CYP2C9 inhibitors (such as ketoconazole, ritonavir, fluconazole, or amiodarone) within 2 weeks of screening or anticipated during the study, or disulfiram or metronidazole.
- People who test positive for drugs of abuse, nicotine, or alcohol at screening or before the first dose on Day 1.
- People who regularly drink more than 10 standard alcoholic drinks per week, or more than 4 standard drinks on any single day.
- People who smoke more than 5 cigarettes (or equivalent nicotine products) per week, or who are unwilling to abstain from smoking or nicotine use during the study.
- Females who are breastfeeding or planning to breastfeed from before the first dose until 90 days after the last dose.
- People who are not able to reliably swallow liquid oral medications daily.
- People who have a current infection requiring antibiotic, antifungal, antiparasitic, or antiviral medication taken systemically within 10 days before the first dose.
- People who have received a live vaccine within 30 days before screening (non-live booster vaccines are acceptable — confirm with trial site).
- People who have taken part in another clinical trial of an investigational drug or device within 30 days or 5 half-lives of that drug (whichever is longer) before screening.
- People who have any other condition or prior treatment that, in the investigator's opinion, would make participation unsuitable, including an inability to cooperate with study requirements.
- People with a history of, or currently experiencing, unexplained repeated vomiting that could affect the assessment of safety or tolerability.
- People with unstable blood pressure or circulation, including clinically significant low blood pressure, high blood pressure, fainting, a fast heart rate, or dizziness upon standing.
- People assessed as having a serious risk of suicide at screening, based on a standard suicide risk assessment (C-SSRS), including those who have reported certain types of suicidal thoughts within the 2 months before screening, or certain suicidal behaviours within the 12 months before screening (confirm specific criteria 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
- 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: Lauren Priest, MD, Division of Rehabilitation, Aged Care and Palliative Care Flinders Medical Centre
Phone: 0482 130 622
Australian sites
0482 130 622
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
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
To assess the efficacy of dronabinol oral solution compared to placebo in reducing agitation in patients with AD.; Change from baseline to Week 12 in the CMAI total score, comparing Dronabinol oral solution versus placebo
Can't join this trial?
Data last synced from ClinicalTrials.gov: 18 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.