Caring for behavioral symptoms of dementia (CBD): A new investigation into cannabidiol for the treatment of anxiety and agitation in Alzheimer’s dementia

Abstract

Background Anxiety and agitation symptoms affect 25‐70% of the dementia population, though there are no FDA‐approved medications that treat the behavioral symptoms of AD. Thus, the need for developing safe and efficacious treatments for anxiety and agitation in AD is dire. One potential treatment is cannabidiol (CBD), the major non‐intoxicating constituent of cannabis sativa, a variety of the cannabis plant that contains <0.3% delta9‐tetrahydrocannabinol (THC), the main intoxicating constituent in cannabis, by weight. The present open‐label clinical trial seeks to address this gap in knowledge by assessing the efficacy and tolerability of a high‐CBD/low‐THC sublingual solution as a treatment for anxiety and agitation in older adults with Alzheimer’s disease. Method An 8‐week open‐label clinical trial of an industrial hemp‐derived high‐CBD/low‐THC sublingual solution. This includes 12 research participants with AD and symptoms of anxiety with or without agitation. Our primary efficacy outcome measures include the anxiety domain of the Neuropsychiatric Inventory‐Clinician Version (NPI‐C) and the Generalized Anxiety Disorder‐7 Item Scale (GAD‐7). Our secondary safety outcome measures include monitoring for serious adverse events and medication side effects, cognitive decline estimates from the Mini Mental Status Exam (MMSE), and the emergence of possible delirium from the Confusion Assessment Method (CAM). Scores on the NPI‐C, the Cohen‐Mansfield Agitation Inventory (CMAI), and caregiver burden estimates from the Zarit Caregiver Burden Interview will be included as additional exploratory measures. Results We hypothesize that twice daily treatment with a high‐CBD/low‐THC solution in older adults with AD for 8 weeks will be associated with a statistically significant reduction in anxiety and agitation symptoms compared to baseline, as measured by our efficacy outcome measurements. We predict that the solution will be well‐tolerated by the study population, as measured by our safety outcome measurements. Conclusion With no current FDA‐approved treatments for these behavioral symptoms, patients with AD risk ineffective therapies or mortality‐associated antipsychotic treatments to address their NPS. Treating anxiety and agitation in these patients not only alleviates their symptoms but could also reduce caregiver burden and lengthen the time to institutionalization. CBD is a promising anxiolytic treatment that could advance our available treatment options for anxiety and agitation in AD.