Study to Analyze Effectiveness of CBD for Neuropsychiatric Symptoms of Alzheimer’s Dementia

Seeking a safe, effective treatment for the neuropsychiatric symptoms of anxiety in older adults with Alzheimer’s dementia (AD), researchers at McLean Hospital, Belmont, Massachusetts, will conduct an 8-week open-label clinical trial and an observational follow up-study of cannabidiol’s (CBD) effectiveness in patients with AD and behavioral symptoms of anxiety.

“There is no current FDA-approved treatment for these neuropsychiatric symptoms of Alzheimer's disease, so a lot of these older folks are being prescribed off-label antipsychotics or [selective serotonin reuptake inhibitors] to treat their neuropsychiatric symptoms such as anxiety and agitation. As a really vulnerable population, they are prone to side effects from these off-label treatments,” researcher Kaitlin R. McManus said.

“We have medicines that have been all repurposed from other psychiatric conditions, and although studied in this population, aren’t completely effective. Certainly there are significant tolerability concerns, and in the case the antipsychotics, risk for death and stroke based on the box warning,” said Brent P. Foster, MD, associate professor of psychiatry at McLean Hospital.

Reducing the Prevalence of Dementia by Modifying Risk Factors

The study will be conducted with an industrial hemp-derived custom-formulated high-CBD/low-tetrahydrocannabinol (THC) sublingual solution developed by Staci Gruber, PhD, at McLean Hospital. Researchers will recruit 12 participants with mild to moderate Alzheimer’s dementia and behavioral symptoms of anxiety, with or without agitation. Dr. Gruber’s team is currently conducting a clinical trial for the treatment of moderate to severe anxiety, and this research team will use the same CBD solution.

The primary efficacy outcome measures will be the anxiety domain of the Neuropsychiatric Inventory-Clinician version (NPI-C) and the Generalized Anxiety Disorder-7 Item Scale (GAD-7). The secondary safety outcome measures will include continuous monitoring for serious adverse events and medication side effects, cognitive decline estimates, and the emergence of possible delirium.

Preliminary results from Dr. Gruber’s study allow researchers to hypothesize that “twice daily treatment with the CBD solution in older adults with AD for 8 weeks will be associated with a statistically significant reduction in anxiety symptoms compared to baseline, as measured by our efficacy outcome measurements.”

Researchers predict that the solution will be well tolerated by the study population, as measured by their safety outcome measurements.

“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,” researchers said.

—Meagan Thistle

Reference

McManus K, Ash E, Harper D, et al. Caring for behavioral symptoms of dementia (CBD): a new investigation into cannabidiol for the treatment of anxiety and agitation in Alzheimer’s dementia. Poster presented at the American Association for Geriatric Psychiatry 2021 Annual Meeting; March 15-19, 2021; Virtual.