A twice-daily oral formulation of cannabidiol (CBD) and tetrahydrocannabinol (THC) rapidly reduces severe agitation in people with advanced dementia who are eligible for hospice care. The Phase 2 LiBBY clinical trial, presented at the Alzheimer’s Association International Conference 2026, shows that this cannabinoid combination offers a new option for a condition that often resists standard treatments.
The Research
Conducted by Dr. Jacobo Mintzer at the Ralph H. Johnson VA Healthcare System and the Medical University of South Carolina, the multicenter, randomized, double-blind, placebo-controlled trial enrolled 120 hospice-eligible dementia patients experiencing significant agitation. Participants received an oral oil formulation containing 2 mg THC and 100 mg CBD per dose, taken twice daily, or a placebo. Dosing started at half-dose (2 mg THC/100 mg CBD total daily) for the first week and increased to full dose (4 mg THC/200 mg CBD total daily) for weeks 2 through 12.
The primary endpoint was change in agitation scores on the Cohen-Mansfield Agitation Inventory at Week 2. The treatment group showed a 6.27-point greater reduction than placebo, reaching statistical significance. Benefits were sustained through Week 12, with an 8.23-point greater reduction. Clinician-rated global improvement was also striking: at Week 2, 83.9% of treated participants improved vs. 30.5% on placebo; by Week 12, the figures were 87.2% vs. 23.6%.
Importantly, adverse event rates were similar between groups (46.7% vs. 42.4%). Though serious adverse events were higher in the treatment group (23.3%) than placebo (11.9%), investigators confirmed none were related to the study drug. This suggests the therapy is generally well-tolerated in this vulnerable population.
Why It Matters
Agitation affects roughly half of individuals near the end of life with dementia. Currently, available off-label therapies like antipsychotics, benzodiazepines, and opioids carry serious risks, including sedation and increased mortality. Many patients remain symptomatic despite these treatments. This study provides strong evidence for a new, effective approach that could bring comfort and dignity to patients and families during a difficult time.
What You Can Do
If you or a loved one is caring for someone with advanced dementia, discuss these findings with a healthcare provider. While CBD/THC products are not yet widely approved for this use, the study’s results highlight the potential of cannabinoid-based therapies. Always consult a doctor before starting any new treatment.
Source: Neuroscience News
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