To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in Patients With Alzheimer's Disease

Exclusion Criteria

• •1\. Known hypersensitivity to the study drug or any of the study drug ingredients.
• •2\. History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer's ability to participate in the study.
• •3\. History or presence of clinically significant, unstable (not well controlled on medications) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
• •4\. History of recurrent falls (≥2 falls within 6 months prior to Screening) resulting in injury or associated with acute illness, loss of consciousness, or abnormal vital signs, history of fall with fracture within 12 months of Screening.
• •5\. History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
• •6\. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
• •7\. History of clinically significant CNS event and/or diagnosis in the past 5 years, including but not limited to epilepsy, significant CNS trauma, CNS surgery, neurosyphilis, meningitis, encephalitis or meningoencephalitis.
• •8\. Baseline delirium as determined by Confusion Assessment Method (CAM) and Diagnostic and Statistical Manual of Mental Disorders (DSM) - criteria.
• •9\. Commencement of medications that affect the CNS within \<4 weeks prior to first dose of study drug, including but not limited to cannabinoid, benzodiazepines, anti-depressant, and antipsychotic medications.
• •10\. History of major psychiatric disorder(s) in the past 5 years, including but not limited to psychosis and bipolar disorder. Mild psychiatric disorder(s) that is well controlled and stable on medication therapy for \>1 year that is not prohibited on this study may be allowed on a case-by-case basis in discussion with study sponsor, if deemed unlikely to put participant at a higher risk of treatment-related toxicity and/or interfere with the integrity of study outcome.
• •11\. A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit. A negative HCV RNA result is acceptable for enrolment.
• •12\. Medications with significant drug-drug interaction potential:
• •1. Strong CYP3A4 or CYP2C9 inhibitors (e.g., ketoconazole, ritonavir, fluconazole, amiodarone) within 2 weeks of Screening or anticipated need during study
• •2. disulfiram/metronidazole (risk due to alcohol content)
• •13\. Positive drugs of abuse test (for a list of drugs tested refer to Section 11.1.8), cotinine test, or alcohol breath test results at screening and prior to dosing on Day 1.
• •14\. Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer \[4.9% Alc/Vol\], 100 mL wine \[12% Alc/Vol\], or 30 mL spirit \[40% Alc/Vol\]).
• •15\. Patient smokes more than 5 cigarettes or equivalent nicotine-containing products per week, and/or the volunteer is unwilling to abstain from smoking or the use of nicotine-containing products. Note: 1 average cigar = approx. 5 average cigarettes; 1 average pipe session = approx. 5 average cigarettes; 1 average nicotine liquid vape session = 1 average e-cigarette = 1 average cigarette.
• •16\. Females who are breastfeeding or planning to breastfeed from pre-dose to 90 days post last dose
• •17\. Is not able to reliably and regularly swallow liquid oral medications on a daily basis.
• •18\. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to first dose of study drug.
• •19\. Use of live vaccines within 30 days prior to screening. Use of (non-live) booster vaccines is acceptable for enrolment.
• •20\. Participation in another clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening.
• •21\. Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
• •22\. History or current presence of unexplained recurrent vomiting that may confound safety or tolerability assessments.
• •23\. Hemodynamic instability, including clinically significant hypotension, hypertension, syncope, tachycardia or symptomatic orthostatic hypotension.
• •24\. Patients with evidence of serious risk of suicide at screening based on the C-SSRS
• •1. Answers "Yes" on items 4 or 5 (C-SSRS - ideation) with the most recent episode occurring within the 2 months before Screening or,
• •2. 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