Safety and Efficacy of Nabilone in Alzheimer's Disease
Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
Alzheimer's disease (AD) is commonly associated with behavioural changes such as agitation.
Severe agitation 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. Currently prescribed treatments (i.e., antipsychotics)
for agitation in AD do not work in everybody and when they do work the effect is small and
they increase the risk of harmful side effects, including death. As a result, there is an
urgent need for safer medication options. The cannabinoid nabilone can now be prescribed in
capsule form for appetite and pain killing effects. Nabilone's calming effects may benefit
those with agitation, and help the weight loss and untreated pain frequently associated with
agitation. Through a clinical trial, the investigators hope identify the benefits of nabilone
in the treatment of agitation in AD.
The investigators objective is to determine whether nabilone is an efficacious and safe
treatment for agitation, as well as having benefits for pain, weight and behavioural
symptoms. This will be a 14 week clinical trial (participants take nabilone for 6 weeks,
placebo for 6 weeks (order randomized) with 1 week between treatments). The investigators
will assess and compare agitation, weight, pain, memory, behaviour and safety.
Nabilone is a new class of medication that may be a safe and effective treatment for
agitation in AD, with added benefits on appetite and pain. Reducing these symptoms would
increase quality-of-life and reduce caregiver stress.