Life's End Benefits of Cannabidiol and Tetrahydrocannabinol
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Southern California
Collaborators:
Alzheimer's Clinical Trials Consortium Alzheimer's Therapeutic Research Institute Medical University of South Carolina National Institute on Aging (NIA)