This is a phase II, randomized, placebo-controlled, double-blind, parallel-group, multicentre
study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain
in patients with mild to severe dementia, when added to an analgesic treatment with
acetaminophen.
It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo,
when added to an analgesic treatment with acetaminophen, and as measured by a change in
Neuropsychiatric Inventory (NPI) score, after a three week treatment period.
It is expected that this will be due, primarily, to psychoactive effects of Namisol® and
secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is
expected that a reduction in NPS will positively affect quality of life and lead to better
functioning in daily living.