Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

Summary

This 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. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.

Timeline

Start

2023-12-18

Primary completion

2026-04-30

Completion

2026-08-01

Publications

• Cummings JL, Zhong K, Ballard C, Sano M, Mintzer J. Clinical trials for neuropsychiatric syndromes in major and mild neurocognitive disorders: A CONSORT-based approach. Int Psychogeriatr. 2025 Dec;37(6):100107. doi: 10.1016/j.inpsyc.2025.100107. Epub 2025 Jun 24.

Drugs

Indications