Cannabis-Derived Treatment Eases Agitation in Late-Stage Dementia

A phase 2 clinical trial called LiBBY has found that a specific formulation of tetrahydrocannabinol (THC) and cannabidiol (CBD) — two cannabis-derived compounds — significantly reduced agitation in people with advanced dementia compared with placebo. The 12-week, randomized, double-blind, placebo-controlled, multicenter trial enrolled 120 participants to test the treatment for agitation and discomfort in late-stage dementia. The University of Kentucky's Sanders-Brown Center on Aging was one of the academic centers involved, with Kentuckians among the participants.

At week 12, 87.2% of participants who received the THC/CBD treatment showed clinician-rated overall improvement, compared with 23.6% of those on placebo, according to results presented in July at the Alzheimer's Association International Conference in London. Benefits appeared within two weeks and continued through the full 12 weeks, with agitation scores falling by eight points on average. "The effect was really an eight-point reduction in agitation scores," said Greg Jicha, M.D., Ph.D., director of clinical trials at Sanders-Brown. "And that is quite striking."

Researchers also tracked side effects, including excessive sleepiness and behavior changes. Overall adverse event rates were similar between the treatment and placebo groups, and investigators determined none of the serious adverse events reported during the trial were related to the study medication. Jicha said treated patients remained "awake, alert, more comfortable and less agitated" rather than simply sedated — a distinction he said also improved caregivers' quality of life, which the study measured separately.

Jicha cautioned that the results apply specifically to the formulation and dosage tested, not to cannabis or commercially available THC or CBD products generally. Because many participants lived at home with significant physical limitations, Sanders-Brown researchers traveled to meet families across Kentucky, at times driving two hours each way. Sanders-Brown has also launched CARE Compass, a new online resource to help families navigate everyday caregiving challenges in the later stages of dementia.