This study will look at whether nabilone is an effective treatment for agitation in
Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is
one of the most distressing and challenging-to-treat symptoms. Agitation is associated with
faster progression to institutionalization, increased caregiver burden, poorer quality of
life, and increased risk of death. In addition, current pharmacological options show only
modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more
effective treatments for agitation in AD is a clinical and research priority.
Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat
chemotherapy-induced nausea and vomiting.
The PI's research group completed a 6-week double-blind placebo-controlled randomized
cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first
preliminary evidence regarding the safety and efficacy of nabilone in this population. They
found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and
caregiver distress. That study was limited by its sample size and questions remain regarding
the efficacy of nabilone for nutrition and pain and predictors of response. However, the
promising preliminary findings encourage a pivotal, practice-changing phase III trial to
inform clinical practice.
Participants in this study will be randomized to receive either nabilone or a placebo for 8
weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the
researchers will also look at whether it is beneficial for other relevant outcomes for
patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition,
nutritional status, and pain. Participants will also be followed for 8 weeks following
completion of the study treatment.
Phase:
Phase 3
Details
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborators:
Alzheimer's Drug Discovery Foundation Alzheimer’s Drug Discovery Foundation Weston Brain Institute