|The following article is part of conference coverage from the 2018 Alzheimer’s Association International Conference in Chicago, Illinois. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAIC 2018.|
CHICAGO — Nabilone, a synthetic cannabinoid, significantly improves agitation, cognition, neuropsychiatric symptoms, and nutrition in patients with moderate to severe Alzheimer disease, according to preliminary data presented at the 2018 Alzheimer’s Association International Conference, July 22-26, 2018 in Chicago, Illinois.
The randomized, double-blind, placebo-controlled cross-over trial enrolled 39 patients with moderate to severe Alzheimer disease (Mini-Mental Status Exam [sMMSE] ≤24) and clinically significant agitation (Neuropsychiatric Inventory [NPI]-agitation/aggression subscore ≥3) from long-term care or outpatient psychiatry clinics. Researchers evaluated 6 weeks of nabilone 1-2 mg vs placebo with a 1-week washout between treatment phases. The primary outcome was agitation, as assessed by the Cohen Mansfield Agitation Inventory (CMAI). Safety, overall neuropsychiatric symptoms (NPI total), cognition, and global impression were secondary outcomes.
The data showed an estimated treatment difference in CMAI score of b =-4.0 (95% CI, -6.5 to -1.5; P =.003) in favor of nabilone with no cross-over (P =.11) or treatment order (P =.85) effects. Also, study authors did not find significant differences in NPI-agitation/aggression (b =-1.5; P =.001), NPI total (b =-4.6; P =.004), and sMMSE score (b =1.1; P =.026).
Regarding Clinician’s Global Impression of Change (CGIC), 47% of patients experienced improvement while receiving nabilone vs 23% of patients during the placebo phases. Sedation, however, was more common among patients who received nabilone vs placebo (45% vs 16%), with no difference seen in treatment-limiting sedation. Treatment with nabilone was favorable on the Mini-Nutritional Assessment-Short Form (b =0.2; P =0.03) but not on the Pain Assessment in Advanced Dementia Scale (b =.03; P =.82).
Although treatment with nabilone significantly improved agitation, cognition, and nutrition, the authors cautioned that sedation should be closely monitored. “A large trial with nabilone to provide confirmatory evidence regarding the efficacy and safety of nabilone in this patient group is warranted,” stated lead author Krista L. Lanctot, PhD from the Sunnybrook Research Institute, Toronto, Ontario, Canada.
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Lanctot KL, Ruthirakuhan M, Gallagher D, et al. Nabilone significantly improves agitation/aggression in patients with moderate-to-severe AD: preliminary results of a placebo-controlled, double-blind, cross-over trial. Presented at: 2018 Alzheimer’s Association International Conference. July 22-26, 2018; Chicago, IL. Oral presentation F4-02-04.