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Life's End Benefits of Cannabidiol and Tetrahydrocannabinol — LiBBY  

Dementia Clinical Trial

Official title:
Life's End Benefits of CannaBidiol and TetrahYdrocannabinol (LiBBY)

Clinical Trial 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 150 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 24 week optional open-label extension will be offered to participants who complete the double-period.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05644262
Study type Interventional
Source University of Southern California
Contact ATRI Recruitment Unit
Phone 213-821-0569
Email libby-participate@usc.edu
Status Recruiting
Phase Phase 2
Start date December 18, 2023
Completion date December 2025
View Details
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