The LiBBY trial found that twice-daily purified THC and CBD oil reduced agitation in hospice-eligible people with late-stage dementia. Adult children should not seek the same treatment yet because the formula is investigational, not FDA-approved, and safety concerns remain. Agitation means restlessness, aggression, shouting, or distress that makes daily care unsafe or exhausting.
The trial enrolled a group rarely included in dementia research. Participants averaged 80 years old and received care through home visits across 10 U.S. sites, according to the Alzheimer's Association. This was an end-of-life, hospice-eligible population with Alzheimer's or another dementia.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Table of Contents
- What did LiBBY test?
- How much did agitation improve?
- Why do safety results limit next steps?
- What should adult children do now?
What did LiBBY test?
LiBBY was a 12-week Phase 2 trial in 120 hospice-eligible people with dementia and agitation. Each person received either twice-daily oral 2 mg THC with 100 mg CBD in oil or a matching placebo, as described in the Alzheimer's Association release.
The study used home visits rather than clinic visits. That design fit people too frail or distressed to travel. The trial was conducted through the NIA-funded Alzheimer's Clinical Trial Consortium, coordinated by USC ATRI with MUSC and Georgetown investigators.
How much did agitation improve?
Agitation scores fell more on active treatment by week 2 and stayed lower through week 12. NeurologyLive reported an overall CMAI AUC contrast of minus 8.23 versus placebo in its trial summary. CMAI is a caregiver-rated scale that counts restless, aggressive, and repetitive behaviors.
Clinician ratings also favored treatment. Improvement reached 83.9 percent at week 2 and 87.2 percent at week 12 on active drug, versus 30.5 percent and 23.6 percent on placebo. The gap appeared early, which matters when families face daily distress and disrupted sleep.
Why do safety results limit next steps?
Overall adverse events looked similar, at 46.7 percent on drug versus 42.4 percent on placebo, according to NeurologyLive. Serious events were higher on drug, at 23.3 percent versus 11.9 percent. Deaths were also higher, at 13.1 percent versus 5.1 percent.
Those numbers need careful reading in hospice-eligible care. People near the end of life already face high medical risk, so a small 120-person trial cannot show whether the drug raised the risk. For an adult child, the practical point is direct: benefit does not yet outweigh proven safety.
What should adult children do now?
Do not substitute a dispensary or over-the-counter cannabis product. The investigators said the result applies only to the purified supervised T2:C100 formulation and dosing system, not other cannabis products. Dose, purity, and supervision change both effect and risk.
Stay with the current care plan and ask the medical team about approved options. The combination is investigational and not FDA-approved, while Rexulti brexpiprazole remains the cited FDA-approved option after its May 11, 2023 supplemental approval for Alzheimer's agitation, according to the FDA approval notice. Bring a one-week log of agitation episodes, sleep, pain, and medicines to the next hospice or dementia-care visit.
- Track when agitation happens, what came before it, and what helped
- Ask about pain, hunger, thirst, constipation, infection, sleep loss, and medicine side effects
- Review sedatives, anticholinergics, opioids, and recent dose changes with the clinician or pharmacist
- Ask the hospice or palliative team about behavior-first calming steps and crisis contact numbers
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