Overview
- The LiBBY Phase 2 randomized, double-blind trial of 120 hospice-eligible people with dementia found the THC/CBD oral formulation reduced agitation scores by 6.27 points more than placebo at two weeks and by 8.23 points more at 12 weeks on the Cohen-Mansfield Agitation Inventory.
- Clinician global ratings favored the active drug strongly, with 83.9% of treated participants judged improved at two weeks and 87.2% improved at 12 weeks versus about 30% and 24% for placebo respectively.
- The tested drug, called T2, used a stepped dose that started with 2 mg THC plus 100 mg CBD twice daily in week one and moved to 4 mg THC plus 200 mg CBD twice daily for weeks 2–12.
- Overall adverse event rates were similar between groups but serious adverse events occurred more often in the treatment arm (23.3% versus 11.9%), a pattern investigators reported as unrelated to the drug and that requires further analysis.
- The trial is one of the first rigorous studies in a hospice-eligible dementia population and its completed 12-week open-label extension plus peer review, full safety analyses and larger confirmatory trials will determine whether this approach can change care for people with late-stage agitation.