Pain Clinical Trial
Official title:
Safety and Efficacy of Nabilone in Alzheimer's Disease: a Pilot Study
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.
Objectives: The investigators objective is to provide pilot data addressing whether the
∆9-tetrahydrocannabinol (THC) analogue nabilone is a pharmacological option for managing
agitation, a particularly difficult to treat neuropsychiatric symptom (NPS), as well as
having benefits for pain, weight and overall NPS, and gather double-blind information on
tolerability and safety. This group of symptoms is particularly prevalent in patients with
moderate to severe AD.
Rationale: The high prevalence and impact of agitation in patients with moderate to severe
Alzheimer's disease (AD) makes this neuropsychiatric symptom (NPS) a key determinant of
decreased quality of life. Associated with agitation are weight loss, and pain, both of which
lead to additional loss of quality of life. Agitation frequently necessitates use of
antipsychotics, which, while well-studied, have modest efficacy and severe side effects
including increased mortality. With the development of synthetic THC analogues, the
therapeutic potential of cannabinoids can now be evaluated. Cannabinoids can be prescribed as
capsules to treat anorexia and pain in certain patient groups. In addition to these
potentially beneficial effects on appetite and pain, a recent study suggested positive
effects of nabilone on agitation in dementia. Importantly, in addition to psychotropic
effects, emerging evidence suggests neuroprotective (inhibit Aβ-induced microglial activation
and excitotoxicity) and anti-inflammatory abilities, which can decrease oxidative stress, in
stark contrast to the negative effects of antipsychotics. As such, this system is of high
potential relevance in agitated patients with AD.
Research Plan: This will be a randomized cross-over study comparing 6 weeks of nabilone and
placebo, with a 1 week placebo washout preceding each treatment phase in Long-term care (LTC)
patients, and outpatients with moderate to severe AD and agitation. Study outcomes will be
measured at baseline and end of treatment for each treatment phase. The primary outcome
measure will be the Cohen-Mansfield Agitation Inventory (CMAI). The secondary outcomes will
be the weight (kg), overall NPS (Neuropsychiatric Inventory (NPI)), NPI agitation/aggression
subscale, nutrition (Mini Nutritional Assessment - Short Form (MNA-SF), body mass index
(BMI), skin fold thickness), pain (The Pain Assessment In Advanced Dementia (PAINAD)),
cognition (Mini-Mental State Examination (MMSE); Severe Impairment Battery (SIB)) and
clinical significance (Alzheimer's Cooperative Study-Clinician Global Impression of change
(ADCS-CGIC). Safety (heart rate, blood pressure, and adverse events) will also be assessed at
every visit.
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