Alzheimer’s disease (AD) is commonly associated with behavioural changes, which can be disabling for patients and caregivers. Specifically, agitation, characterized by irritability and physical restlessness, is important to treat because it not only increases progression of AD and physical health problems (increased falls and weight loss), but it also decreases quality of life and increases caregiver stress. Current treatments for agitation in AD do not work in everybody and when they do work, the effect is small and they increase risk of harmful side effects, including death. As a result, there is an urgent need for safer medication options.

Recently, cannabinoids such as nabilone, which are chemical compounds with calming effects, have emerged as a promising alternative for the treatment of agitation in AD. In a small pilot study, we found that nabilone improved agitation, behaviour, caregiver stress and memory with an acceptable safety profile over 6 weeks. We also found that blood markers predicted agitation severity and improvement in agitation following treatment. A longer trial in more patients is needed to confirm those findings and determine whether nabilone is also beneficial for weight loss, untreated pain and memory.

Our aim is to evaluate nabilone for the treatment of agitation in AD. We propose an 8-week clinical trial with participants randomized to take either nabilone or placebo. We will assess and compare agitation, behaviour, memory, weight, nutrition, pain and safety between the treatment groups. We will also take blood to assess markers of treatment response.    

Nabilone is a new class of medication that may be safe and effective for agitation in AD, with added benefits for other common symptoms of AD. This study is supported by strong pilot data and findings have the potential to change clinical practice and inform personalized medical care.