Regular Research ArticleTetrahydrocannabinol in Behavioral Disturbances in Dementia: A Crossover Randomized Controlled Trial
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Study Design
This was a multicenter, phase II, repeated crossover, randomized, double-blind, placebo-controlled trial, conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and International conference on Harmonization guidelines and registered at www.clinicaltrials.org (NCT01302340). The study took place at the Alzheimer Centre of the Radboud University Medical Center (Radboud UMC, Nijmegen, The Netherlands) and the Vincent van Gogh Institute (Venray, The Netherlands), between
Conclusions
In the present study, we found no benefit of THC treatment (0.75 mg and 1.5 mg, twice daily) on NPS in dementia on either of the outcome measures. Although THC failed to improve NPS, intermittent treatment demonstrated safety in older dementia patients. Previous studies all showed positive effects of THC (2.5 to 7.0 mg, daily) on behavioral and nighttime disturbances,13, 14, 34, 35 although two of these studies were randomized controlled trials with a small number of patients (N = 2; N = 15),14
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