Topline results from the Phase 2 LiBBY clinical trial show that a medically formulated oral THC-CBD combination rapidly and significantly reduces agitation in advanced, hospice-eligible dementia patients. At Week 2, treated participants showed a 6.27-point greater reduction in agitation scores than those on placebo, with benefits sustained through Week 12. Clinician-rated global improvement reached 87.2% in the treatment group. Researchers caution that these results apply only to this specific medical formulation and not to commercial cannabis products.
LiBBY trial THC-CBD results
- ▪A Phase 2 clinical trial named LiBBY showed that a combination of THC and CBD rapidly and significantly reduces agitation in hospice-eligible people with dementia.
- ▪The experimental cannabinoid medication used in the LiBBY trial differs substantially from commercially available or over-the-counter cannabis products.
- ▪The LiBBY trial evaluated a novel oral formulation of 2 mg THC and 100 mg CBD dissolved in digestible oil, administered twice daily.
End-of-life dementia agitation
- ▪Agitation affects approximately half of people living with dementia near the end of life.
- ▪More than one-third of people with dementia continue to experience agitation despite off-label treatment with benzodiazepines, opioids, and antipsychotics.
Primary secondary endpoint measures
- ▪At Week 2, participants receiving the THC/CBD formulation showed a 6.27-point greater reduction in agitation scores on the Cohen-Mansfield Agitation Inventory than those receiving placebo.
- ▪Clinician-rated global improvement was reported for 83.9% of treated participants at Week 2 and 87.2% at Week 12, compared to 30.5% and 23.6% for the placebo group, respectively.
Adverse event rates
- ▪Overall adverse event rates were similar between the treatment and placebo groups, recorded at 46.7% and 42.4%, respectively.
- ▪Over 12 weeks, 23.3% of participants in the treatment arm experienced serious adverse events compared with 11.9% in the placebo arm, though investigators determined none were related to the study medication.
Hospice-eligible population research
- ▪The LiBBY trial is among the first randomized, controlled trials conducted in a hospice-eligible population with dementia.
- ▪The LiBBY trial was a 12-week, multicenter study conducted across 10 U.S. sites, primarily funded by the National Institute on Aging.
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