The LiBBY trial tested a purified THC-CBD oil for agitation in hospice-eligible people with late-stage dementia. It gives no direct efficacy or safety evidence for people with mild cognitive impairment.
Mild cognitive impairment means thinking or memory changes that are noticeable but do not block daily tasks. Agitation means restlessness, aggression, or distress that threatens comfort and safety. Families often ask whether a dementia finding applies earlier.
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
- Who took part in LiBBY?
- What treatment and design were tested?
- How large were benefits and harms?
- Why don't these results apply to mild cognitive impairment?
Who took part in LiBBY?
LiBBY enrolled 120 hospice-eligible participants with Alzheimer's or other dementia and clinically significant agitation. Mean age was 80. Care took place across 10 U.S. sites, with visits at homes or residences.
NeurologyLive describes this enrollment and home-based design in NeurologyLive's July 25 report. The Alzheimer's Clinical Trial Consortium describes the population as advanced major neurocognitive disorder with agitation. That stage brings high frailty and round-the-clock care needs. It differs sharply from mild cognitive impairment.
What treatment and design were tested?
Participants received purified oral T2:C100 oil with 2 mg THC plus 100 mg CBD twice daily. The control was matching placebo. The Alzheimer's Association states the product was a study formulation in digestible oil, not dispensary or over-the-counter cannabis, in the Association's AAIC release.
LiBBY was a 12-week, multicenter, randomized double-blind placebo-controlled Phase 2 trial. Topline results were first reported at AAIC 2026 in London on July 14, 2026. The LiBBY Study site notes funding from the U.S. National Institute on Aging and leadership through the Alzheimer's Clinical Trial Consortium.
How large were benefits and harms?
Cohen-Mansfield Agitation Inventory scores fell 10.61 points on THC-CBD versus 4.35 on placebo at week 2. The inventory rates the frequency of agitated behaviors. Separation persisted through week 12. MIMS Hong Kong reported this primary-endpoint result from the AAIC presentation in its AAIC news report. Clinician-rated global improvement reached 83.9% on THC-CBD versus 30.5% on placebo at week 2.
By week 12, the rates were 87.2% versus 23.6%. NeurologyLive reports these clinician ratings in NeurologyLive's July 25 report. Safety showed similar overall adverse-event rates in the two groups. Serious events were more common on THC-CBD, at 23.3% versus 11.9%. According to the same NeurologyLive summary, serious infections were 11.7% versus 1.7%, and deaths were 13.1% versus 5.1% in frail end-of-life patients.
Why don't these results apply to mild cognitive impairment?
LiBBY studied only hospice-eligible advanced dementia with agitation. The Alzheimer's Clinical Trial Consortium listing defines that narrow population. It therefore provides no direct evidence on benefit or risk for mild cognitive impairment. End-of-life goals, drug sensitivity, and causes of distress differ from early cognitive change.
A sedating effect that eases distress near death can harm attention, balance, and driving safety earlier. Other causes of restlessness also dominate earlier, such as poor sleep, pain, mood change, and medicine effects. For new restlessness, worry, or irritability with mild cognitive impairment, practical next steps are: MCI care focuses on daily function, safety, and treatable causes under routine medical follow-up. Comfort-focused hospice care uses closer supervision and different trade-offs. Bring notes on triggers, sleep, medicines, and recent changes so the clinician can act quickly.
- Track what happens before, during, and after each episode.
- Bring full medicine, sleep, pain, mood, alcohol, and caffeine lists to the visit.
- Ask about hearing, vision, sleep apnea, depression, and medicine side effects.
- Do not substitute dispensary or over-the-counter cannabis for the study oil.
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