THC-CBD combo eases agitation in advanced dementia trial

A purified THC-CBD oil suspension eased agitation in hospice-eligible patients with advanced dementia in a phase 2 trial that followed people at home or in their places of residence. The multicenter, randomized, double-blind, placebo-controlled study enrolled 120 participants with Alzheimer’s disease or another dementia, and the average age was 80.

The LiBBY trial, short for Life’s end Benefits of cannaBidiol and tetrahYdrocannabinol, was presented at the Alzheimer’s Association International Conference in London. Ten medical centers nationwide took part, and the primary outcome was assessed after two weeks, with follow-up at 12 weeks. By the end of that period, close to 90% of treated participants showed overall improvement.

Jacobo Mintzer, a physician at the Medical University of South Carolina, and Brigid Reynolds, a nurse practitioner at Georgetown University, led the study. Reynolds said agitation can bring restlessness, aggression and emotional distress for patients and caregivers. Mintzer called the response unusually strong for a dementia trial. The formulation is a rapid-acting digestible oil suspension of purified THC and CBD.

Agitation is one of the most distressing symptoms of dementia and can drive emergency department visits and long-term-care placement. Johns Hopkins Medicine estimates that agitation affects about 40% of people with Alzheimer’s disease, and it says Alzheimer’s affects about 6.7 million Americans age 65 and older, a figure projected to reach 13.8 million by 2060.

The new results build on earlier work suggesting cannabinoids may help calm some people with dementia. In 2024, Johns Hopkins and Tufts researchers found that synthetic THC, or dronabinol, lowered agitation in Alzheimer’s disease by about 30% on average and did so with calming effects similar to antipsychotics, without adverse events such as delirium or seizures. Other smaller studies and reviews point in the same direction, but the record has remained thin and mixed.

The Alzheimer’s Association says there is very little scientific evidence on cannabis and cannabis-derived products in Alzheimer’s disease or other dementias, and that cannabis is not approved by the Food and Drug Administration for dementia treatment. It says larger, controlled trials are still needed before safety and effectiveness can be judged with confidence.