A first-of-its-kind study conducted by researchers from the Alzheimer’s Association and multiple universities across the USA has demonstrated that cannabis has the ability to reduce agitation in patients living with late-stage dementia.
The multicenter, randomised, double-blind, placebo-controlled study, named Life’s End Benefits of cannaBidiol and tetrahYdrocannabinol, or LiBBY for short, was published on the Alzheimer’s Association website and was first announced at the Alzheimer’s Association International Conference.
The study found that cannabis oil made from a combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) can swiftly and significantly reduce agitation in dementia patients better than a placebo after two weeks of treatment, and sustain the reduction for the duration of the 12-week study.
Agitation experienced by dementia patients often manifests as distressing vocal outbursts, pacing, hostility, and physical aggression. It is thought to affect roughly 50% of dementia patients and is the main reason that families give for having to move their loved ones into residential care accommodation.
Historically, agitation has been treated with heavy sedatives and antipsychotics, drugs that can often have a negative effect on patients by increasing confusion, lowering quality of life, and raising the risk of early death.
Researchers administered a novel 50:1 CBD to THC cannabis oil, with a total daily dose of 8mg THC and 400mg CBD to 120 late-stage dementia patients. The cohort was made up of 55% females and had a mean age of 80.5, and all were eligible for care within a hospice.
During the study, patients were administered the cannabis treatment daily for 12 weeks. Researchers assessed patients on agitation and change of condition at the beginning of the study as well as at the 2- and 12-week marks.
Patients’ agitation was graded using the Cohen-Mansfield Agitation Inventory (CMAI) at each stage of the study, and change in condition was also measured using the Clinical Global Impression of Change in Behavior (CGIC-B).
The results showed a ‘statistically significant’ improvement in CMAI scores at the 2- and 12-week points, and also in CGIC-B scores at the 12-week point, when compared to placebo.
“This trial shows that high-quality clinical research can and should be conducted in people with advanced dementia, including those receiving hospice-eligible care,” said lead investigator Jacobo Mintzer, M.D. “That is essential for achieving equitable and meaningful progress in Alzheimer’s treatment.”
“This is a robustly positive, randomized, controlled trial that represents a major step forward in treatment for a population that has been historically overlooked in clinical research,” Mintzer added.
“We now have evidence supporting a new and very effective treatment approach for agitation that may be appropriate for people in the final stages of dementia at the end of life, offering them grace and peace in what is often an extremely difficult time for patients and their families.”
Alzheimer’s and other dementia-based illnesses are thought to affect 55 million people globally. Agitation affects about half of people living with dementia near the end of life, and more than one-third continue to experience symptoms despite off-label treatment with benzodiazepines, opioids and antipsychotics – therapies that can be difficult to manage and carry significant risks. The LiBBY trial is among the first randomised controlled trials in a hospice-eligible population, demonstrating that people living with late-stage dementia can take part in and provide valuable clinical data in medical studies.
