THC/CBD Reduced Agitation in Hospice-Eligible Dementia Trial

Key Takeaways

• In hospice-eligible or hospice-enrolled people with dementia and clinically significant agitation, a randomized, double-blind, placebo-controlled Phase 2 trial reported that oral THC/CBD met its primary and key secondary endpoints.
• Agitation improved significantly with the THC/CBD regimen versus placebo, with separation evident by Week 2 and sustained through Week 12.
• Clinician-rated global improvement was reported in 83.9% versus 30.5% of participants at Week 2 and 87.2% versus 23.6% at Week 12 with active treatment versus placebo.
• Overall adverse events were similar between groups, while serious adverse events were numerically higher with active treatment, and investigators reported that none were related to study medication.

End-of-life agitation in advanced dementia is common, distressing, and often difficult to control with existing off-label options. Topline findings from the LiBBY trial were presented at the Alzheimer’s Association International Conference (AAIC) 2026 in London and online, adding randomized data in a population with limited evidence and few clearly effective therapies.

The LiBBY Phase 2 AAIC 2026 topline findings in hospice-eligible dementia agitation described a multicenter, randomized, double-blind, placebo-controlled 12-week Phase 2 trial in 120 participants with dementia who were eligible for or receiving hospice care and had clinically significant agitation. Conducted through the National Institute on Aging (NIA)-funded Alzheimer’s Clinical Trial Consortium (ACTC), the study evaluated an oral oil formulation called T2, described as containing 2 mg tetrahydrocannabinol (THC) and 100 mg cannabidiol (CBD) per unit dose, given twice daily, with a half-dose period in Week 1 and a higher dose from Weeks 2 through 12. The primary endpoint was change in agitation on the Cohen-Mansfield Agitation Inventory (CMAI) at Week 2.

The investigators reported a 6.27-point greater reduction in CMAI agitation scores with THC/CBD versus placebo at Week 2, a statistically significant difference, followed by an 8.23-point greater reduction versus placebo at Week 12. Clinician-rated global improvement also favored active treatment, reaching 83.9% versus 30.5% at Week 2 and 87.2% versus 23.6% at Week 12 for THC/CBD and placebo, respectively. Safety findings showed overall adverse events in 46.7% versus 42.4% and serious adverse events in 23.3% versus 11.9%, with investigators stating that zero serious adverse events were related to study drug.

According to the investigators, people with advanced dementia near the end of life have often been underrepresented in trials despite substantial symptom burden. The available coverage described agitation as affecting about half of people with dementia near the end of life, with more than one-third remaining symptomatic despite off-label therapy, which helps explain why this population was studied. At the same time, the available evidence consists of conference topline findings described in a secondary news account rather than a peer-reviewed full trial publication, so the signal is limited to what has been reported publicly so far.

Investigators also reported that a 12-week open-label extension has been completed and is expected to be presented at AAIC 2026. Overall, the LiBBY trial was reported to meet its primary and key secondary endpoints, with rapid separation from placebo by Week 2 and sustained benefit through Week 12 in people with dementia who were eligible for or receiving hospice care.

Clinician Questions

What was the primary endpoint in the LiBBY trial for agitation in hospice-eligible dementia?

The primary endpoint in the LiBBY trial was change in agitation on the Cohen-Mansfield Agitation Inventory at Week 2 in people with dementia who were eligible for or receiving hospice care and had clinically significant agitation.

How large was the reported agitation benefit with THC/CBD versus placebo in hospice-eligible advanced dementia?

In hospice-eligible people with dementia, the THC/CBD intervention was reported to produce a statistically significant 6.27-point greater reduction versus placebo on the Cohen-Mansfield Agitation Inventory at Week 2 and an 8.23-point greater reduction at Week 12.

What safety results were reported with T2 in the LiBBY dementia agitation trial?

In the LiBBY dementia agitation trial, overall adverse events were reported as 46.7% with T2 versus 42.4% with placebo, serious adverse events as 23.3% versus 11.9%, and investigators said zero serious adverse events were related to study drug.