CHICAGO—Nabilone, a synthetic cannabinoid, may effectively treat agitation in people with Alzheimer’s disease, according to a randomized, double-blind clinical trial presented at AAIC 2018.
“Agitation, including verbal or physical outbursts, general emotional distress, restlessness, and pacing, is one of the most common behavioral changes associated with Alzheimer’s disease as it progresses and can be a significant cause of caregiver stress,” said Krista L. Lanctôt, PhD, Senior Scientist at Sunnybrook Health Sciences Centre and Professor of Pharmacology and Psychiatry at the University of Toronto.
Dr. Lanctôt and colleagues investigated the potential benefits of nabilone for adults with moderate-to-severe Alzheimer’s dementia and clinically significant agitation. During the 14-week trial, 39 participants (77% male; average age, 87) received nabilone in capsule form (mean therapeutic dose, 1.6 mg) for six weeks, followed by one week without treatment and six weeks of placebo. In addition to measuring agitation, the researchers assessed overall behavioral symptoms, memory, physical changes, and safety.
Dr. Lanctôt’s group found that agitation improved significantly when participants were taking nabilone, compared with when they were receiving placebo, as measured by the Cohen-Mansfield Agitation Inventory. Nabilone also significantly improved overall behavioral symptoms, compared with placebo, as measured by the Neuropsychiatric Inventory.
In addition, the researchers observed small benefits in cognition and nutrition when participants received nabilone during the study. More people in the study experienced sedation when taking nabilone (45%) than when taking placebo (16%).
“Currently prescribed treatments for agitation in Alzheimer’s disease do not work in everybody. And when they do work, the effect is small, and they increase the risk of harmful side effects, including increased risk of death. As a result, there is an urgent need for safer medication options,” said Dr. Lanctôt. “These findings suggest that nabilone may be an effective treatment for agitation; however, the risk of sedation must be carefully monitored. A larger clinical trial would allow us to confirm our findings regarding how effective and safe nabilone is in the treatment of agitation for Alzheimer’s disease.”The FDA has not approved marijuana for the treatment or management of Alzheimer’s disease or other dementias. The use of marijuana as medical treatment is increasingly common, but much about the drug’s use in people with Alzheimer’s disease or other dementias is unknown. No robust, consistent clinical trial data support marijuana for the treatment of Alzheimer’s disease dementia or for related issues.