To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in P… (NCT07422311) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in Patients With Alzheimer's Disease
Australia140 participantsStarted 2026-05-01
Plain-language summary
This study tests a medication called dronabinol in people with Alzheimer's disease. First, participants go through up to 4 weeks of screening. Then, over 2 weeks, the dose of the study drug is slowly increased. For the next 10 weeks, participants stay on either dronabinol or a placebo.
After finishing this part of the study, participants can join a 6-month extension where everyone receives dronabinol. Those already on the drug stay on their same dose, while those who were on placebo gradually increase their dose over 2 weeks.
All participants take dronabinol for the rest of the extension, then complete a final safety check 4 weeks after stopping the medication. Usual medical treatments are continued throughout the study.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Read and understand consent documents and questionnaires
. Hear and respond to verbal instructions for cognitive testing
. Participate in clinical interviews
. Absolute Neutrophil Count ≥1500/mm3; or 1.5 x 109/L
. Platelet count ≥100,000/mm3; or 1.0 x 109/L
. Hemoglobin ≥8 g/dL
. Adequate renal function characterized by estimated creatinine clearance ≥50 mL/min Chronic Kidney Disease Epidemiology Collaboration equation (CKDEPI).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the efficacy of dronabinol oral solution compared to placebo in reducing agitation in patients with AD.
Timeframe: 12 weeks
2
Change from baseline to Week 12 in the CMAI total score, comparing Dronabinol oral solution versus placebo
. Total bilirubin ≤1.5 x ULN (≤3 x ULN for participants with Gilbert's syndrome).
Exclusion criteria
. Strong CYP3A4 or CYP2C9 inhibitors (e.g., ketoconazole, ritonavir, fluconazole, amiodarone) within 2 weeks of Screening or anticipated need during study
. disulfiram/metronidazole (risk due to alcohol content)
. Answers "Yes" on items 4 or 5 (C-SSRS - ideation) with the most recent episode occurring within the 2 months before Screening or,
. Answers "Yes" to any of the 5 items (C-SSRS - behavior) with an episode occurring within the 12 months before Screening, except for the participant having responded "Yes" to engaging in non-suicidal injurious behavior