Oral Cannabinoid From MediPharm Shows Significant Reduction in Agitation in Alzheimer Disease and Dementia

The phase 2 Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol (LiBBY) trial met its primary endpoint, showing improvement in agitation symptoms in patients with Alzheimer disease or other dementia.¹ An open-label extension supported durability of response and continued benefit from MediPharm’s proprietary oral cannabinoid formulation. Results were presented at the 2026 Alzheimer’s Association International Conference.²

"The positive LiBBY study results shared today represent an important milestone for patients living with advanced dementia, their families, and the advancement of cannabinoid-based medicines. The study findings are encouraging and add important clinical evidence in an area of urgent unmet need,” said Greg Hunter, interim chief executive officer of MediPharm Labs.¹ “These findings support further evaluation of our proprietary formulation as a treatment option for agitation in advanced dementia, and reinforce the pharmaceutical standards we have built, in service of patients who need new options," he added.

This phase 2 study evaluated an oral combination of THC and CBD for treatment of agitation in hospice-eligible patients with Alzheimer disease or other dementia. The randomized, double-blind, placebo-controlled trial included 120 participants with multiple centers and a 12-week treatment period, followed by an optional open-label extension phase for eligible participants. Participants received either placebo or the novel oral formulation of 2 mg THC/100 mg CBD twice a day. Eligible participants were individuals with dementia who were eligible to receive or receiving hospice care and experiencing clinically significant agitation.

The LiBBY study achieved its primary endpoint, demonstrating statistically significant improvement in agitation symptoms at week 2, measured by the Cohen-Mansfield Agitation Inventory (CMAI). At week 2, the treatment group showed a 6.27-point greater reduction in CMAI agitation scores compared with placebo, indicating rapid symptom relief. The trial continued to show sustained treatment benefits through the 12-week treatment period, and open-label extension findings supported durability of response and continued benefit. At week 12, treatment group participants showed an 8.23-point greater reduction in agitation scores compared with placebo. Statistically significant improvements were also observed in overall clinical status for the treatment group vs placebo.

Clinician-rated global improvement showed 83.9% improvement in treatment vs 30.5% in placebo at week 2, and 87.2% improvement in treatment vs 23.6% improvement in placebo at week 12. Overall adverse event rates were similar between treatment and placebo groups. By week 12, 23.3% of participants receiving treatment experienced serious adverse events vs 11.9% in placebo; investigators noted none of the serious adverse events were determined to be related to the study medication.

Developers of the cannabinoid formulation are reviewing the study results and evaluating next steps, include potential regulatory activity, additional clinical development opportunities, and collaboration.

References

1. MediPharm Labs announces positive phase 2 LiBBY trial results demonstrating significant reduction in agitation associated with advanced Alzheimer disease and dementia. Press release. July 14, 2026. Accessed July 15, 2026. https://www.globenewswire.com/news-release/2026/07/14/3326864/0/en/medipharm-labs-announces-positive-phase-ii-libby-trial-results-demonstrating-significant-reduction-in-agitation-associated-with-advanced-alzheimer-s-disease-and-dementia.html

2. Topline results from LiBBY trial show THC/CBD combination significantly reduces agitation for people with dementia at end of life. Alzheimer’s Association International Conference. July 14, 2026. Accessed July 15, 2026. https://aaic.alz.org/releases-2026/libby-trial-thc-cbd-agitation-late-stage-dementia.asp