Eastern Virginia Medical School
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.
Individuals with Alzheimer's and other forms of dementia often go through a period of significant behavioral and psychological symptoms of dementia (BPSD). It is estimated that up to 90% of persons with dementia (PWD) experience behavior problems at some point. BPSDs can be challenging for both unpaid family caregivers as well as paid caregivers. Family caregivers provide the bulk of care for PWD and number over 15 million. One of the most common types of BPSDs is agitation with a prevalence of up to 87%, based on a recent systematic review. Agitation can lead to impaired daily functioning, pr…
Inclusion Criteria: * 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…
Hemp-based CBD oil Gelcaps
Placebo Gelcaps
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