End-of-life stages for people with dementia are unpredictable but agitation is a common symptom. The final stages of dementia may last days, weeks, or months. The grieving process can be more difficult when the person who is dying experiences significant agitation. Around fifty percent of people diagnosed with Alzheimer’s disease (AD) or other types of dementia will receive hospice care at the end of their life. Of these, over seventy percent will be prescribed psychiatric medications for management of agitation. There are no approved treatments or guidelines to assist clinicians in addressing end of life agitation in dementia. In the absence of appropriate evidence-based guidelines, patients are typically prescribed a combination of anti-psychotics, sedatives, and opiates. These medications often lead to undesirable side effects including confusion, constipation, itching, tremors, and muscle contractions, all of which tend to make the situation even worse, lowering quality of life for patients, and adding burden to their care partners.
Recent research suggests that derivatives of cannabis (some of the chemicals found in marijuana) can be beneficial in controlling agitation and distress without the side effects of medications commonly used to treat agitation. In this clinical trial, we have chosen to use a combination of two medications, Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) for the treatment of agitation in participants with a diagnosis of dementia who are eligible for hospice and experiencing agitation.
The LiBBY trial will recruit 150 participants from around 15 clinical trial sites in the United States over a 2 year period. Individuals in the study will have the option to participate in a 3-month open-label extension study. Read more about LiBBY here: https://libbystudy.org
Over the course of 12 weeks, study participants will receive a THC/CBD oral combination versus placebo in the form of a digestible oil. A total daily dose of 8 mg of THC and 400 mg of CBD will be administered 2 times per day with a maximum of 4 mg of THC and 200 mg of CBD per dose.
“We’re testing a new treatment for a condition that’s common and often devastating,” said Brigid Reynolds, MSN, ANP-BC the Co-Principal Investigator of the study and faculty at Georgetown University. “We hope physicians and caregivers will be interested in helping to enroll participants in this trial, as the benefits could be significant. This effort may lead to even larger trials that could expand our knowledge of the possibilities of this potential new treatment.”
The LiBBY Study began enrolling participants in December 2023, and is projected to complete in 2025.
ACTC Solution
This trial included a number of inherent challenges that come with clinical trials of a Schedule 1 drug. The LIBBY study was designed in close consultation with experts in hospice and palliative care. ACTC identified companies to provide and package the investigational product, as well as consultants to guide clinical trial sites through approval requirements. Input on study conduct was requested from the ACTC Research Participant Advisory Board as well as investigator sites, on how to minimize burden on the study participants and families during this sensitive time.