Start: February 26, 2021
End: March 2024
What Is This Study About?
This Phase 2 study will evaluate the effectiveness of cannabidiol (CBD) oil to reduce agitation in people with Alzheimer's disease and lessen caregiver burden. Participants will be randomly assigned to take a capsule of CBD oil or placebo twice a day for six weeks and complete questionnaires during the 15-week study. Researchers will evaluate changes in agitation, aggression, and quality of life for the person with dementia, as well as caregiver burden. Researchers will also assess changes in other behavioral and psychological symptoms of dementia, cognitive function, and sleep quality.
Do I Qualify To Participate in This Study?
- Diagnosis of Alzheimer's disease or mixed dementia, in which Alzheimer's is combined with another type of dementia
- Mini-Mental State Exam score of 4-28
- Moderate to severe agitation/aggression with Neuropsychiatric Inventory test score for agitation/aggression > 3
- If taking cognition-enhancing medications (e.g., cholinesterase inhibitors and/or memantine), the dosage must be stable for at least one month prior to starting the study; or if discontinued, participation may begin after 15 days
- If taking antidepressants, the dosage must be stable within four weeks prior to group assignment and during the study
- If taking antipsychotics or benzodiazepines, the dosage must be stable for a week prior to group assignment and during the study
- Caregivers must either live with the participant or have a minimum of four hours of daily contact
- Fluent in English (reading, writing, and speaking)
Must NOT have:
- Any serious or unstable medical illness including heart, liver, kidney, respiratory, endocrine, neurologic, or blood disease
- Serious psychiatric disorders or neurological conditions (e.g., psychotic disorders, bipolar disorder, or schizophrenia)
- Current abuse of marijuana, alcohol, and/or other drugs
- Any seizure disorder
- Pregnant or breastfeeding
- Evidence of delirium
- Unable to swallow a soft gel pill
- Use of lithium, tricyclic antidepressants, fluoxetine, and/or carbamazepine
- History of hypersensitivity to any cannabinoid (e.g., marijuana)
- Frequent falling due to sudden low blood pressure when standing up from sitting or lying down
- Living in a nursing home
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
David Elkins, MS
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Eastern Virginia Medical School
Old Dominion University
Ananda Hemp, Inc.
Source: ClinicalTrials.gov ID: NCT04436081