Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
Eastern Virginia Medical School
Summary
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.
Description
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…
Eligibility
- Age range
- 50–90 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTHC-free CBD Oil
Hemp-based CBD oil Gelcaps
- DrugPlacebo
Placebo Gelcaps
Location
- Eastern Virginia Medical SchoolNorfolk, Virginia