MediPharm Labs reports positive Phase II LiBBY trial results showing significant improvement in agitation among patients with advanced Alzheimer’s disease and dementia.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
MediPharm Labs has announced positive results from the Phase II LiBBY (Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol) clinical trial (NCT05644262) evaluating its proprietary oral cannabinoid formulation for the treatment of agitation in patients with advanced Alzheimer’s disease and other dementias. The findings were presented by the LiBBY study team at the Alzheimer’s Association International Conference (AAIC) held in London, United Kingdom, on July 14, 2026. The study provides encouraging clinical evidence for a potential new treatment approach in an area where effective therapeutic options remain limited.
Disease Background
Agitation is a common and distressing complication of advanced Alzheimer’s disease and other dementias, particularly among patients receiving hospice care. Approximately 50% of people with dementia receive hospice care during the final stage of life, and more than 70% are prescribed psychiatric medications to manage agitation. Current treatment often relies on antipsychotics, sedatives and opioids, which may reduce symptoms but are frequently associated with adverse effects, reduced quality of life and increased caregiver burden, highlighting the need for better treatment options.
About the LiBBY (Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol) Study
The LiBBY study was a randomized, multicentre, double-blind, placebo-controlled Phase II clinical trial evaluating MediPharm Labs’ proprietary oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD). The formulation was developed, manufactured and supplied exclusively by MediPharm Labs. The double-blind treatment period lasted 12 weeks and was followed by an optional open-label extension to assess the durability of treatment response.
The trial enrolled hospice-eligible patients with Alzheimer’s disease or other dementias experiencing agitation. It was led by investigators at the Keck School of Medicine of the University of Southern California and funded by the National Institute on Aging, part of the U.S. National Institutes of Health, with additional support from the Alzheimer’s Association. The study was conducted through the Alzheimer’s Clinical Trials Consortium and coordinated by the USC Epstein Family Alzheimer’s Therapeutic Research Institute in collaboration with academic research centres across the United States.
The study met its primary endpoint, demonstrating a statistically significant improvement in agitation symptoms compared with placebo at Week 2, as measured by the Cohen-Mansfield Agitation Inventory (CMAI). Improvement was evident within two weeks of treatment initiation and was maintained throughout the 12-week double-blind treatment period. Participants receiving the cannabinoid formulation also demonstrated statistically significant improvement in overall clinical status compared with placebo. Findings from the open-label extension further supported the durability of response, indicating that clinical benefits were maintained over time in eligible participants.
The topline announcement did not include detailed safety or tolerability findings, including adverse event rates or treatment-related complications. Consequently, the overall benefit-risk profile cannot yet be fully assessed, and interpretation of the efficacy findings should await publication of the complete clinical dataset.
Pharmaceutical Development and Next Steps
The LiBBY study also highlights MediPharm Labs’ pharmaceutical development capabilities. The company developed and manufactured the investigational formulation and supplied clinical trial materials into the United States through a regulated cross-border supply chain.
MediPharm Labs stated that it retains ownership of the proprietary formulation and related intellectual property, including rights to use study data to support future regulatory submissions, patent filings and additional research initiatives. Following the positive Phase II findings, the company is evaluating potential regulatory activities, further clinical development opportunities and strategic collaborations to advance the program.
What Does It Mean for Patients?
For patients and caregivers, the results offer encouraging evidence in an area of substantial unmet medical need. The observed reduction in agitation, beginning as early as two weeks after treatment initiation and sustained throughout the study period, suggests that this oral cannabinoid formulation warrants further clinical investigation. However, additional studies and comprehensive safety data will be required to determine its overall benefit-risk profile and potential role in routine clinical practice. Overall, the Phase II findings provide important clinical evidence supporting continued investigation of cannabinoid-based therapy for agitation associated with advanced Alzheimer’s disease and other dementias.
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About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.