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Key Takeaways
- The LiBBY trial found that an oral THC/CBD formulation reduced agitation in 87.2% of hospice-eligible dementia patients by Week 12, significantly outperforming placebo.
- Conducted as a multicenter, randomized, double-blind trial, the study focused on a vulnerable population often overlooked in research.
- Agitation affects roughly half of dementia patients near the end of life, and traditional treatments often carry serious risks.
- The study demonstrated that cannabis-derived compounds can offer meaningful improvements in agitation symptoms for dementia patients without cognitive suppression.
- LiBBY’s diverse participant profile shows the possibility of equitably recruiting underrepresented populations in clinical trials, a milestone in dementia research.
A Phase 2 clinical trial called LiBBY, recently presented at the Alzheimer’s Association International Conference in London on July 14th, found that a purified oral THC/CBD cannabis oil formulation reduced agitation in 87.2% of hospice-eligible dementia patients by Week 12, compared to just 23.6% on placebo, with statistically significant results appearing within just two weeks.
For families who have watched a loved one with late-stage dementia cycle through restlessness, verbal outbursts, and physical distress, treatment options have always been painfully limited. Sedatives. Antipsychotics. Opioids. Medications that often trade one form of suffering for another.
That may be starting to change. Funded by the National Institute on Aging as part of the NIH, LiBBY is among the first randomized, controlled studies ever conducted specifically in a hospice-eligible dementia population, and researchers are calling its outcomes some of the most positive ever seen in a dementia behavioral study.
What Was the LiBBY Trial, and Why Does It Study Design Matter?
LiBBY stands for Life’s End Benefits of cannaBidiol and tetrahYdrocannabinol. That name tells you exactly what the researchers were after: a therapeutic tool for people at the very end of life, a population that has historically been left out of clinical research.
The study was a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial conducted across multiple U.S. sites. It enrolled 120 participants who had Alzheimer’s disease or another dementia-causing condition, all of whom were eligible for or receiving hospice care and experiencing clinically significant agitation.
The drug being tested, labeled T2:C100, was an oral oil formulation containing 2mg THC and 100mg CBD dissolved in a digestible oil, taken twice daily. During the first week, participants received a half dose. From Week 2 through Week 12, the full dose doubled to 4mg THC and 200mg CBD twice daily.
Lead investigator Jacobo Mintzer, M.D., a psychiatrist at the Ralph H. Johnson VA Healthcare System and professor at the Medical University of South Carolina, described the results as “a robustly positive, randomized, controlled trial that represents a major step forward in treatment for a population that has been historically overlooked in clinical research.”
Why Is Dementia-Related Agitation So Difficult to Treat?
Agitation affects roughly half of all people living with dementia near the end of life. It shows up as pacing, repetitive movements, sudden vocal outbursts, verbal hostility, and in some cases physical aggression. In the late stages of dementia, people often lose the ability to communicate verbally, so agitation frequently becomes the only way they can express their distress.
Here is the part that does not get discussed enough: existing treatments fail to address agitation in more than one-third of dementia patients. Benzodiazepines, opioids, and antipsychotics are the standard tools, and all three carry serious risks in elderly populations. They can increase confusion, reduce quality of life, and in some cases accelerate cognitive decline.
The FDA has now approved two medications specifically to treat agitation in Alzheimer’s-related dementia. Rexulti (brexpiprazole), approved in 2023, was the first. Auvelity (dextromethorphan-bupropion), a non-antipsychotic option, followed in early 2026. But a substantial portion of patients still do not respond adequately to either.
The LiBBY trial directly targeted this gap: a hospice-eligible population with few good options and no time to waste.
What Did the LiBBY Trial Find at the Two-Week Mark?
The study’s primary endpoint was the change in agitation scores on the Cohen-Mansfield Agitation Inventory (CMAI) at two weeks. Researchers chose two weeks, not the more typical four-to-six-week window used in psychiatric trials, because many hospice-eligible patients simply do not have months to wait for a medication to work.
By Week 2, participants receiving the THC/CBD formulation showed a 6.27-point greater reduction in CMAI scores compared to those on placebo. That difference was statistically significant, with a p-value of 0.0004, meaning there is less than a 0.04% chance the result was due to chance.
Clinician-rated global assessments told the same story. At the two-week mark, 83.9% of treated participants showed improvement versus just 30.5% in the placebo group.
What Did the Study Find at 12 Weeks?
The benefits did not fade. By Week 12, the CMAI score gap had grown to 8.23 points in favor of the THC/CBD group, with a p-value under 0.0001. Clinician-rated improvement at 12 weeks reached 87.2% in the treatment group, compared to 23.6% for placebo.
Nearly nine in ten patients. That kind of response rate is rare in psychiatric research under any circumstances. In a population this medically complex, it is extraordinary.
Co-principal investigator Brigid Reynolds, APRN, a nurse practitioner with the Memory Disorders Program at Georgetown University, said: “One of the most meaningful aspects of these findings is the potential to provide a more humane and dignified experience for patients and families. Reducing agitation can help restore a sense of calm and comfort in a very vulnerable time.”
A 12-week open-label extension phase was also completed and reported at AAIC 2026. Patients who switched from placebo to active treatment in the extension phase saw measurable reductions in agitation, and safety held steady across the full 24-week observation period.
Was the THC/CBD Formulation Safe to Use?
Overall adverse event rates were comparable between the two groups, at 46.7% in the treatment arm versus 42.4% for placebo. Serious adverse events occurred in 23.3% of treated participants compared to 11.9% on placebo. However, investigators determined that none of the serious adverse events were related to the study medication itself. The adverse events observed were consistent with what researchers expected to see in an elderly, hospice-eligible population.
One critical distinction the research team made repeatedly is worth emphasizing: the T2:C100 formulation used in the LiBBY trial is not the same as anything currently available at a dispensary or online. The medication was a pharmaceutical-grade, precisely measured oil suspension produced under clinical supervision. As Reynolds noted, “Over-the-counter or commercially available THC and CBD products may vary widely in their composition, quality, and dosing, making them potentially ineffective or even harmful” in this population.
That is not a dig at cannabis. That is a reminder that pharmaceutical precision and dispensary products operate in completely different frameworks, and that distinction matters when you are treating a frail 80-year-old in hospice care.
LiBBY Was a Research Equity Win
One of the most meaningful findings received far less attention: who was actually enrolled in this study.
The participant profile in LiBBY looked like this: mean age of about 80 years, 55% female, 75% living in community settings rather than care facilities, and 58% from historically underrepresented ethnoracial communities.
That last figure is a big deal. Dementia research has a long and well-documented problem with underrepresentation. Researchers have historically recruited white and more affluent participants for clinical trials, meaning they have tested treatments on populations that do not reflect the groups who actually experience the highest rates of dementia.
Black Americans are approximately twice as likely to develop Alzheimer’s disease compared to white Americans, according to the Alzheimer’s Association, yet they remain significantly underrepresented in most trials.
Paul Aisen, M.D., director of the Epstein Family Alzheimer’s Therapeutic Research Institute at the University of Southern California and a principal investigator of the Alzheimer’s Clinical Trial Consortium, addressed this directly: “The LiBBY study successfully demonstrated that it is feasible to recruit, enroll, and retain a representative cohort from this group, including individuals from historically underrepresented communities.”
What Does This Mean for Caregivers Who Are Watching a Loved One Struggle?
Many dementia researchers describe agitation as one of the most distressing symptoms — not just for patients, but for the people caring for them. It is also one of the leading reasons families make the painful decision to move a loved one into memory care or a nursing facility.
The LiBBY study homepage notes directly that one of its stated goals was to “reduce caregiver burden and patient suffering.” That framing is telling. This was never just about a clinical score on a questionnaire. It was about giving people with dementia a chance at more peaceful final months, and giving their families something back, too.
Laura, whose mother participated in the LiBBY trial, shared her experience with Neuroscience News and Cannabis Health News following the results announcement. She did not know whether her mother received the active drug or placebo, but she observed changes that mattered to her. “She seemed happier,” Laura said. “We experienced joy. There were still moments of connection.”
That is the real story underneath the p-values.
Why Does Cannabis Work for Dementia Agitation? The Science Behind the Results
Most coverage of the LiBBY trial reported what happened. Fewer outlets took time to explain why cannabis may work in this context at all.
Multiple peer-reviewed journals, reviewed by Project CBD, have found that Alzheimer’s disease directly disrupts the endocannabinoid system in the brain. Postmortem analysis has revealed that CB1 cannabinoid receptor expression decreases in Alzheimer’s brains, while CB2 receptor expression increases, particularly around amyloid plaques, the protein aggregates considered a hallmark of the disease.
In plain terms: the brain’s own cannabinoid signaling system appears to be thrown off balance by Alzheimer’s. CBD and THC, which interact with both CB1 and CB2 receptors, may work in part by modulating that disrupted system rather than simply sedating a patient the way opioids or benzodiazepines do.
That is a fundamentally different mechanism, and it may help explain why the THC/CBD formulation in LiBBY produced behavioral improvement without the cognitive suppression and increased fall risk associated with traditional sedatives.
Where Does Cannabis-Based Dementia Treatment Go From Here?
The LiBBY trial is a Phase 2 study. That means it is not the end of the road; it is the point where a treatment demonstrates enough promise to justify the larger, more expensive Phase 3 confirmatory trials required for FDA approval. That path takes years and is not guaranteed.
Federal cannabis policy did shift in 2026, with regulators reclassifying FDA-approved and state-licensed medical marijuana products from Schedule I to Schedule III. That reclassification does not extend to investigational treatments like the T2:C100 formulation used in LiBBY, which remains Schedule I until it completes its own FDA approval pathway.
What the LiBBY results do is move the conversation in a direction that was not possible five years ago. They show that cannabis-derived compounds, when properly formulated and administered, can produce measurable, sustained, and clinically meaningful improvements in one of dementia’s most difficult symptoms. They show that hospice-eligible patients can participate in rigorous clinical research. And they show that the conversation about cannabis as medicine in end-of-life care is no longer speculative.
Elizabeth Edgerly, Ph.D., Alzheimer’s Association vice president of care and support, put it directly: “These results not only highlight a promising therapeutic option, but also underscore the importance of prioritizing attention, care and research for individuals in mid- and late-stage Alzheimer’s and related dementias.”
That attention is long overdue.
Frequently Asked Questions
The LiBBY trial was a federally funded clinical study that tested a THC/CBD oil on 120 dementia patients experiencing agitation. By week 12, 87.2% of treated participants showed improvement compared to just 23.6% on placebo, with benefits appearing within two weeks.
Researchers from the LiBBY trial strongly advise against using consumer cannabis products as a substitute for the trial’s treatment. Unlike the pharmaceutical-grade oil used in the trial, dispensary or online cannabis products vary in composition, purity, and dosing, making them unsafe for elderly dementia patients without medical supervision.
Research suggests that the endocannabinoid system, which regulates mood, pain, and neurological signaling, is disrupted in Alzheimer’s disease. CBD and THC interact with cannabinoid receptors around amyloid plaques, potentially helping to manage dementia’s neuropsychiatric symptoms rather than simply sedating patients.
In just two weeks, the treatment produced significant results. Participants showed a 6.27-point greater reduction in agitation scores compared to the placebo group. Researchers chose this short timeframe deliberately, as hospice patients need fast-acting solutions.
