The Phase 2 LiBBY trial tested twice-daily oral T2:C100 for agitation in hospice-eligible people with late-stage dementia. People with only mild cognitive impairment were not studied, so the findings do not apply to them.
Mild cognitive impairment, or MCI, means noticeable memory or thinking changes while daily independence stays largely intact. Late-stage dementia removes that independence and creates round-the-clock care needs. That difference shapes who LiBBY can inform.
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 was studied?
- Why were people with MCI not included?
- What changed for the late-stage group?
- What limits and safety issues matter for MCI?
Who was studied?
According to NeurologyLive, LiBBY enrolled 120 hospice-eligible people with dementia and agitation across 10 U.S. sites, with visits in homes or residences NeurologyLive report. Participants averaged 80 years old, with 55% female, 84% White, and 45% Hispanic or Latino.
Treatment was twice-daily oral T2:C100, containing 2 mg THC plus 100 mg CBD, against placebo for 12 weeks. The focus was agitation, a state of restlessness, pacing, yelling, or aggression that distresses the person and caregivers. This was a frail, advanced-illness group receiving hospice-linked care. Their medical risks, drug responses, and care goals differ sharply from people living independently with MCI.
Why were people with MCI not included?
According to the CenterWatch trial listing, eligibility required DSM-5 major neurocognitive disorder plus hospice enrollment or advanced-dementia thresholds CenterWatch listing. Those thresholds were FAST stage 6D or an ADEPT score of 12 or higher. MCI does not meet major neurocognitive disorder criteria.
It also does not meet hospice-eligible or advanced-dementia thresholds. So a person with only MCI would fail screening. Useful checks for families reading the criteria are:.
- diagnosis is major dementia, not MCI alone
- person meets hospice or advanced functional criteria
- agitation is present and being tracked
- care happens under close supervision
What changed for the late-stage group?
According to the Pennington Biomedical Research Center, CMAI agitation scores fell 10.61 points on THC/CBD versus 4.35 points on placebo at week 2, a 6.27-point difference Pennington announcement. CMAI, the Cohen-Mansfield Agitation Inventory, rates how often agitated behaviors occur. Benefit persisted through week 12, with clinician-rated improvement reaching 87.2% on active treatment versus 23.6% on placebo.
These numbers describe the studied late-stage group only. They do not show that THC, CBD, or a combined product sharpens memory, slows MCI, or prevents dementia. They also do not set a dose for earlier-stage symptoms.
What limits and safety issues matter for MCI?
Overall adverse-event rates were similar, but serious events were more common on THC/CBD. According to NeurologyLive, serious infections occurred in 11.7% versus 1.7% and deaths in 13.1% versus 5.1% NeurologyLive safety report. A hospice-eligible population already faces high background illness and death.
The findings also apply only to the purified supervised T2:C100 formulation and dosing system, not to dispensary or over-the-counter cannabis. People with MCI should not use LiBBY to judge store products as helpful or safe. For MCI, the practical step is to track thinking changes, sleep, mood, medications, and safety, then bring that record to primary care or dementia care. Ask what supports daily function and what trials actually enroll people with MCI.
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