The Cannabinoid Promises to Reduce Agitation and Aggression in Alzheimer's Disease

July 25, 2018

Although treatment with nabilone significantly improves agitation, cognition, and nutrition, the authors warn that sedation should be closely monitored.

CHICAGO – Nabilone, a synthetic cannabinoid, significantly improves agitation, cognition, neuropsychiatric symptoms, and nutrition in patients with moderate-to-severe Alzheimer's disease, according to preliminary data presented at the International Conference of Alzheimer 2018, July 22-26, 2018 Chicago, Illinois.

The randomized, double-blind, placebo-controlled crossover trial recruited 39 patients with moderate-to-severe Alzheimer's disease (Mini-Mental Status Exam [sMMSE] ≤24) and a clinically active significant (Neuropsychiatric Inventory [NPI] -agitation / aggression subscore ≥3) long-term care clinics or outpatient psychiatry. The researchers evaluated 6 weeks of nabilone 1-2 mg vs placebo with a 1 week wash between the treatment phases. The main result was agitation, as badessed by the Cohen Mansfield Agitation Inventory (CMAI). Safety, overall neuropsychiatric symptoms (total NPI), cognition, and overall impression were secondary outcomes.

The data showed an estimated difference in treatment of the CMAI score of b = -4.0 (95% CI, -6.5 to -1.5; P = 0.003 ) in favor of nabilone without crossing ( P = .11) or from a processing order ( P = .85) effects. In addition, the study authors did not find any significant differences in NPI-agitation / aggression ( b = -1.5; P = 0.001 ), Total NPI ( b = -4.6; P = 0.004), and the sMMSE score ( b = 1.1; P = 0.026).

Regarding the overall impression of change clinician (CGIC), 47% of patients experienced improvement while taking nabilone versus 23% of patients during placebo phases. Sedation, however, was more common in patients who received nabilone compared to placebo (45% vs. 16%), with no difference in sedation limiting treatment. The treatment with nabilone was favorable on the nutritional mini-evaluation – short form ( b = 0.2; P = 0.03) but not on the scale d & Evaluation of pain in advanced dementia ( b) = .03; P = .82).

Although treatment with nabilone significantly improves agitation, cognition, and nutrition, the authors warn that sedation should be closely monitored. "An important trial with nabilone to confirm the efficacy and safety of nabilone in this group of patients is warranted," said lead author Krista L. Lanctot, Ph.D. of Sunnybrook Research Institute, Toronto, Ontario, Canada.

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Reference

Lanctot KL, Ruthirakuhan M, Gallagher D, et al. Nabilone significantly improves agitation / aggression in patients with moderate to severe AD: Preliminary results from a double-blind, placebo-controlled crossover trial. Presented at: 2018 International Conference of the Alzheimer's Association. July 22-26, 2018; Chicago, IL. Oral presentation F4-02-04.