To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in Pā¦ (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 range50 Years ā 90 Years
SexALL
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Inclusion criteria
ā. Read and understand consent documents and questionnaires
ā. Hear and respond to verbal instructions for cognitive testing
ā. Participate in clinical interviews
ā. Absolute Neutrophil Count ā„1500/mm3; or 1.5 x 109/L
ā. Platelet count ā„100,000/mm3; or 1.0 x 109/L
ā. Hemoglobin ā„8 g/dL
ā. Adequate renal function characterized by estimated creatinine clearance ā„50 mL/min Chronic Kidney Disease Epidemiology Collaboration equation (CKDEPI).
ā. Total bilirubin ā¤1.5 x ULN (ā¤3 x ULN for participants with Gilbert's syndrome).
Exclusion criteria
ā. Strong CYP3A4 or CYP2C9 inhibitors (e.g., ketoconazole, ritonavir, fluconazole, amiodarone) within 2 weeks of Screening or anticipated need during study
ā. disulfiram/metronidazole (risk due to alcohol content)
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
ā. Answers "Yes" on items 4 or 5 (C-SSRS - ideation) with the most recent episode occurring within the 2 months before Screening or,
ā. 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