The study is the LiBBY study and it’s a study that was inspired by a lady by the name of Libby who spent the last few weeks of her life in substantial distress and suffering from the side effects of the medication that was given to her. About half of the patients that suffer from Alzheimer’s disease would end the last days of their life in hospice care, and 70% of them will suffer from agitation...
The study is the LiBBY study and it’s a study that was inspired by a lady by the name of Libby who spent the last few weeks of her life in substantial distress and suffering from the side effects of the medication that was given to her. About half of the patients that suffer from Alzheimer’s disease would end the last days of their life in hospice care, and 70% of them will suffer from agitation. And the agitation will cause incredible suffering on the patient by distressing the family and interfere with the ability of the patients to die the last few days of their life with grace and dignity. And therefore, we decided to study and develop a treatment that will treat that symptom, allowing the patients to die surrounded by the people they love in peace. And that was the objective of the LiBBY study. The LiBBY study was a double-blind, placebo-controlled, randomized trial for the treatment of agitation in hospice-eligible Alzheimer patients and people suffering from other types of dementia. The special preparation that we used was a combination of THC and CBD that was conceived by the study team and manufactured by a company in Canada called Metapharm. The results of the study could not have been more clear. The primary outcome measure was the Cohen-Mansfield Agitation Inventory, which evaluates the amount of, sorry, that evaluates the frequency of behaviors such as hitting, kicking, grabbing, shouting, that patients manifest in these stages of life. The difference between the drug and placebo was six points at two weeks, which was a primary outcome measure, and showed highly significant results. The second outcome measure was the Cohen-Mansfield agitation inventory at 12 weeks, and that was analyzed using an area under the curve, and the difference was -8.25 points between drug and placebo. It was interesting to observe that after two weeks, the placebo groups remained stable, but the group on the drug continued to improve throughout the 12 weeks of the double-blind study. At 12 weeks, there were eight deaths in the drug group and three deaths in the placebo group, none of these deaths were considered to be related to the study drug. About the clinical significance of these findings, at two weeks, 83% of the patients were considered to be improved in the drug versus around 30% in the placebo group. At 12 weeks, 87% of the people were considered to be responders by a blinded rater versus 23%, if I’m correct, in the placebo group. So it was highly significant. And what does it mean? We proved the most important thing is that treatment for this population has been basically based on clinical practice rather than in double-blind controlled trials. This shows the feasibility to do this type of trial in this population was so desperately needed. Our study also was one of the first few that used purified THC and CBD in the treatment of this population. Finally, the studies were highly positive, but I need to clarify that this applied only to the specific formulation used in the study and does not apply to medical marijuana or any other form of cannabis that people can obtain. The specific treatment is not publicly available, was developed for research purposes only. And next plans will be to expand these findings into a broader population.
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