The psychiatry and pharmacology professor spoke about the results from the first clinical trial that showed that a cannabinoid can decrease agitation in Alzheimer disease.
“What we found when we gave this medication was that we did have a statistically significant decrease in agitation.”
According to data Krista Lanctôt, PhD, psychiatry and pharmacology professor at the University of Toronto, presented at the 2018 Alzheimer’s Association International Conference, in Chicago, Illinois, nabilone, a synthetic cannabinoid, significantly improved agitation, cognition, neuropsychiatric symptoms and nutrition in those with moderate to severe Alzheimer disease.
The Sunnybrook Health Sciences Centre researcher sat down with NeurologyLive to discuss the results of a randomized, double-blind, cross-over clinical trial, funded by Alzheimer's Drug Discovery Foundation and Alzheimer Society of Canada, that investigated the potential benefits of nabilone for adults with moderate to severe Alzheimer’s dementia with clinically significant agitation.
Lanctôt and colleagues investigated the potential benefits of nabilone over a 14-week period where participants received nabilone for 6 weeks, followed by 6 weeks of placebo, with 1 week between each treatment period.
In addition to measuring agitation, researchers studied overall behavioral symptoms, memory, physical changes and safety, concluding that nabilone offered clinically and statistically significant improvements in agitation when compared with placebo, as measured by the Cohen-Mansfield Agitation Inventory (P = .003), and significantly improved overall behavioral symptoms, versus placebo, as measured by the Neuropsychiatric Inventory (P = .004).
Lanctôt stressed that the occurrence of sedation be closely monitored, as 45% of participants on nabilone experienced sedation compared to 16% that received placebo.
While there are still questions regarding the cognitive effects nabilone has on patients, overall, there was a slight improvement in the Mini-Mental Status Examination score in a subgroup population with more severe dementia.
The benefits of nabilone also went beyond the patient, as caregiver distress showed a significant reduction. For this patient population, a larger trial is needed to provide confirmatory evidence regarding and safety of nabilone. Being as this is a proof-of-concept trial, this trial is more so a signal, rather than leading to changes in clinical practice guidelines.