Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants' quality of life.
• Males/females over 50 years old.
• Have a diagnosis of dementia due to AD or mixed AD with another type of dementia.
• A Mini-Mental State Exam score (MMSE) between 4 and 28 inclusive.
• Presence of agitation with a Neuropsychiatric Inventory (NPI)-agitation/aggression subscore \> 3.
• Participants and their informal caregivers must be fluent in English (includes reading, writing, and speech) and able to give informed consent.
• For patients treated with cognitive-enhancing medications (cholinesterase inhibitors (ChEI) and/or memantine), the dosage must be stable for at least 1 month (30 days). If the ChEI and/or memantine has been discontinued, patients may enroll after 15 days.
• Eligible caregivers must either live with the participant or have a minimum of 4 hours of daily contact with them.