The Life's end Benefits of CannaBidiol and TetrahYdrocannabinol (LiBBY) is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks.
This study will enroll approximately 120 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks.
The LiBBY Open-Label Extension (OLE) Study provides the researchers with the opportunity to further evaluate the effects of the THC/CBD oral combination as a treatment for agitation in HAD. The OLE study is designed to determine whether the benefits of THC/CBD are sustained over time, and whether participants initially receiving placebo can also benefit from the treatment. Additionally, the OLE study seeks to explore whether prolonged treatment with THC/CBD improves lifespan, quality of life, and caregiver burden—areas insufficiently studied in terminally ill dementia patients.