A cannabis-based oral treatment combining THC and CBD showed significant reductions in agitation among hospice-eligible adults with advanced dementia in a Phase II trial.
A new Phase II clinical trial suggests that cannabis-based treatment help ease one of the most distressing symptoms of advanced dementia. Researchers found that an oral formulation combining purified tetrahydrocannabinol, or THC, and cannabidiol, or CBD, significantly reduced agitation in people with advanced dementia compared with placebo.
The findings come from the LiBBY trial, or Life’s End Benefits of cannaBidiol and tetrahYdrocannabinol, and were presented at the Alzheimer’s Association International Conference 2026 in London.
Dementia is an umbrella term for conditions that cause a decline in memory, thinking, reasoning and daily functioning. Alzheimer’s disease is the most common cause, but dementia can also result from vascular disease and other brain disorders.(1✔ ✔Trusted Source
Dementia
In advanced dementia, agitation can become a major challenge for patients, families and caregivers.
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THC-CBD Treatment Reduced Agitation in Advanced Dementia
The multicenter, randomized, double-blind, placebo-controlled Phase II trial enrolled 120 hospice-eligible adults with Alzheimer’s disease or other forms of dementia.
All participants were experiencing significant agitation.
Participants received either the THC-CBD oral formulation or a placebo for 12 weeks.
Researchers measured agitation using the Cohen-Mansfield Agitation Inventory, along with clinician evaluations of behavioral improvement.
The cannabis-based treatment group showed significantly greater reductions in agitation than the placebo group.(2✔ ✔Trusted Source
Alzheimer’s Association International Conference. THC/CBD Reduces Agitation in Late-Stage Dementia. 2026.
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Agitation Symptoms Improved Rapidly With THC-CBD Therapy
Clinician assessments showed improvement in 83.9% of treated participants after two weeks.This compared with 30.5% of participants in the placebo group.
By 12 weeks, improvement was reported in 87.2% of treated participants compared with 23.6% of those receiving placebo.
Nearly 90% of treated participants showed overall clinical improvement during the study.
Researchers described the response as unusually strong compared with previous clinical trials for agitation in dementia.
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Agitation Is a Major Burden in Late-Stage Dementia
Agitation is common in advanced Alzheimer’s disease and other dementias. It may appear as restlessness, pacing, irritability, yelling, emotional distress, aggression or resistance to care.
These symptoms can be deeply distressing for the person with dementia.They also place a heavy emotional and physical burden on caregivers, especially when agitation disrupts sleep, feeding, hygiene, safety or daily care routines.
Managing agitation is one of the most difficult parts of late-stage dementia care.
Current Agitation Treatments Pose Safety Concerns
Current medications for agitation in dementia are limited. Antipsychotics, sedatives and other drugs may sometimes be used, but they can carry important risks in older adults.
These risks may include excessive sedation, falls, worsening confusion, stroke and increased mortality in some patients.(2✔ ✔Trusted Source
Alzheimer’s Association International Conference. THC/CBD Reduces Agitation in Late-Stage Dementia. 2026.
This creates a difficult balance for clinicians and caregivers. A treatment that reduces agitation without substantially increasing adverse events could be valuable, especially in palliative and hospice-eligible dementia care.
However, any cannabis-based therapy would still need careful medical supervision.
The Trial Used a Controlled Medical Formulation
The trial tested a carefully formulated oral treatment containing purified THC and CBD. This is different from non-prescription cannabis products or recreational cannabis.
The dose, formulation, quality and medical monitoring used in a clinical trial cannot be assumed to apply to over-the-counter products.
People caring for someone with dementia should not attempt cannabis-based treatment without medical guidance.
Older adults with dementia may be more vulnerable to side effects such as sedation, dizziness, confusion, falls or drug interactions.
Larger Studies Are Needed Before Routine Use
Although the Phase II results are promising, the treatment is not yet a routine standard of care.
Larger Phase III trials will be needed to confirm effectiveness, identify risks, define appropriate dosing and determine which patients may benefit most.
Researchers will also need to study long-term safety and whether the treatment affects cognition, mobility, sleep, caregiver burden and quality of life.
Dementia Carries a Growing Global Burden
Dementia affects people’s ability to live independently, communicate, work and manage daily life. It also places a major burden on families, caregivers and health systems.
The World Health Organization estimates that dementia costs the global economy about US$1.3 trillion each year, with around half of that cost linked to unpaid care provided by family members and friends.
As populations age, the need for safer and more effective treatments for dementia-related symptoms is expected to grow.
Cannabis-Based Therapy Could Become a Future Option
The LiBBY trial offers a potential new direction for treating agitation in advanced dementia. The results suggest that a medical THC-CBD formulation may help reduce distressing behavioral symptoms in some patients.
However, the findings should be interpreted carefully. This is an early-stage clinical result, and more research is needed before the treatment can be widely recommended.
For now, the study offers cautious hope for patients and caregivers facing agitation in advanced dementia, while reinforcing the need for safe, evidence-based and closely supervised treatment options.
References:
- Dementia- (https://www.who.int/news-room/fact-sheets/detail/dementia)
- Alzheimer’s Association International Conference. THC/CBD Reduces Agitation in Late-Stage Dementia. 2026.
– (https://aaic.alz.org/releases-2026/overview.asp)
Source-Medindia