Dementia patients using a THC/CBD oral cannabinoid formulation showed a significant reduction in agitation, according to the findings of a new study.
The results come from the Phase II LiBBY trial, a multicenter, randomized, double‑blind, placebo‑controlled study announced this week by MediPharm Labs. Participants in the trial were 120 people with late‑stage Alzheimer’s disease and other dementias who were eligible for or receiving hospice care and experiencing clinically significant agitation.
Researchers administered a proprietary oral formulation combining 2 mg THC and 100 mg CBD in digestible oil to the study participants twice daily. Nearly 90% of participants receiving the THC/CBD treatment showed overall improvement in target symptoms by the end of the 12‑week study, compared to less than one‑quarter of those on placebo.
Agitation Common Among Dementia Patients
Agitation is a common and often severe symptom in late‑stage dementia. It can involve restlessness, pacing, verbal or physical aggression, and emotional distress. These behaviors can escalate quickly, creating safety concerns and placing heavy strain on caregivers. Current medications used to manage agitation often come with risks that make long‑term use difficult, including sedation, cardiovascular complications, and increased fall risk. Families and clinicians have long sought safer options that can reduce agitation without worsening other symptoms.
The primary findings of the LiBBY trial were presented July 14, 2026, at the Alzheimer’s Association International Conference in London by co‑lead researchers Jacobo Mintzer, MD, of the Medical University of South Carolina, and Georgetown University’s Brigid Reynolds, MSN, APRN, ANP‑BC.
“These trial results were extremely impressive and showed a level of response not seen before in clinical trials related to dementia,” said Mintzer, according to a report from Neuroscience News. “Rarely do we see close to 90% of patients in a trial respond positively to a new medication.”
Participants receiving the THC/CBD formulation showed rapid improvements. By week 2, the treatment group had a significantly greater reduction in agitation scores than those on placebo, and benefits were sustained through week 12. Clinician‑rated global improvement also favored the cannabinoid formulation, with more than 80% of treated participants improving at week 2 and nearly 90% improving at week 12, compared to roughly 30% and 24% in the placebo group. Overall adverse event rates were similar between groups, although serious adverse events were more frequent in the treatment group, underscoring the need for continued monitoring as research progresses.
Impact On Patients And Caregivers
Agitation is not only distressing for patients. It also affects caregivers who often struggle to manage unpredictable behaviors while providing daily support. Many families report that agitation episodes are among the most challenging aspects of dementia care, sometimes leading to emergency room visits or transitions to higher‑level care settings. A medication that can reduce agitation without excessive sedation could help patients remain more comfortable and allow caregivers to maintain home routines.
“Agitation affects many people with late‑stage dementia, causing symptoms such as restlessness, aggression, and emotional distress that can profoundly impact patients and their caregivers,” explained Reynolds. “Current treatment options are limited and often carry significant side effects, underscoring the need for safer, more effective therapies.”
Growing Interest In Cannabinoid Therapies
Interest in cannabinoid‑based treatments for dementia has grown as researchers explore how the endocannabinoid system may influence neurodegenerative processes. Early studies have examined whether cannabinoids can reduce inflammation, support neuronal signaling, or improve behavioral symptoms. While results have varied, agitation has emerged as an area where cannabinoids may offer meaningful benefit.
MediPharm Labs says the LiBBY findings support further evaluation of its proprietary THC/CBD formulation in larger studies. If Phase III research confirms these results, families could gain access to a new treatment option aimed at reducing agitation without the heavy side effects associated with current medications.
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