Approximately fifty percent of people diagnosed with Alzheimer’s disease or other types of dementia will receive hospice care at the end of their life. Of these, over seventy percent will be prescribed psychiatric medications for management of agitation. Recent research suggests that derivatives of cannabis can be beneficial in controlling agitation and distress without the side effects of medications commonly used to treat agitation. This project aims to test the efficacy of an oral combination of two cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD), for the treatment of agitation in participants with a diagnosis of dementia who are eligible for hospice and experiencing agitation. The study will recruit 150 participants from 15 clinical trial sites in the United States over a 2-year period. To facilitate recruitment and retention and to monitor long-term safety of the THC/CBD combination, completers of the double-blind study will then have the option to participate in a 6-month, open-label extension study.
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