Life's End Benefits of Cannabidiol and Tetrahydrocannabinol (LIBBY) Trial

Abstract This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC)/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 in hospice care eligible patients with agitation and Alzheimer’s disease (AD) or other types of dementia (HAD) participants as measured by the Cohen-Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. Participants will be randomized 1:1 to receive either T2:C100, an oral combination of THC and CBD in a digestible oil, or placebo. Study drug (T2:C100 or placebo) will be administered as orally, or through a feeding tube, once in the morning and once in the evening. Doses may be given with or without food and may be mixed with anything for easier consumption.