Study to evaluate the benefits of THC, CBD in dementia-related agitation
Pennington Biomedical Research Center's Dr. Jeff Keller is evaluating the potential for delta-9-tetrahydrocannabinol, or THC, and cannabidiol, or CBD, to reduce the behaviors indicating agitation, distress or anxiety in patients with Alzheimer's disease or other forms of dementia.
The study is designed for hospice-eligible patients who are either receiving hospice care or who are eligible for hospice, and who are exhibiting agitation concurrently with a diagnosis of dementia. There are currently no FDA-approved medications to treat agitation at the end-of-life stages in dementia patients.
The "Life's End Benefits of Cannabidiol and Tetrahydrocannabinol" or LiBBY, study is a placebo-controlled, double-blinded study designed to help researchers further explore these compounds for their potential to ease the burden of patients and caregivers.
"The restlessness, anxiety, and distress that frequently accompanies Alzheimer's and dementia can be frustrating and frightening for both the patient and their caregivers," said Dr. Keller, who is the director of the Institute for Dementia Research & Prevention at Pennington Biomedical and a professor of aging and neurodegeneration.
"The LiBBY study intends to explore whether THC and CBD can be safe and effective options for managing agitation in dementia patients. This landmark, multisite study will increase the pace of THC clinical research nationwide, and Pennington Biomedical's participation makes it much easier to initiate THC research at this facility in the future."
Upon joining the study, participants will complete a baseline visit and will be randomly assigned to one of two study groups: one receiving the active study drug, and one receiving a placebo. The active study will last for 12 weeks and will include one screening visit, six in-person visits, and five evaluations by phone.
Before the study concludes, all participants will have the opportunity to request to continue their participation in the "Open Label Extension" portion of the study. Though participants will not know if they are receiving the study drug or the placebo during the study, all participants will receive the active study drug in the "Open Label Extension" period.
"Dementia, especially when coupled with agitation, can be frightening for patients and heartbreaking for caregivers, who frequently face burnout. As other studies have shown THC can help in treating post-chemotherapy nausea, the LiBBY study is a practical next step in exploring the benefits of these compounds and offering hope to those facing this difficult challenge," said Dr. John Kirwan, Executive Director of Pennington Biomedical.
"Dr. Keller and his colleagues have worked incredibly diligently to bring this study to Pennington Biomedical. We are proud to have this study here and to have it position the Center for similar studies in the future."
Pennington Biomedical is one of 11 research institutions to facilitate the LiBBY study and exploring the use of THC for dementia-related agitation. Pennington Biomedical, Georgetown University Medical Center, the University of Kentucky, and the Ralph H. Johnson VA Medical Center are currently recruiting participants.
The research facility is working with hospice care providers in Capital Region and beyond to share the details of this study with patients and their families. Carpenter Health network, a large Baton Rouge-based hospice group, is one of the care providers to help identify patients and caretakers who may be eligible for the study.
"The Carpenter Health Network is proud to join with other late-stage care facilities and networks to share this study with the families we work with daily," said Raoul Manalac, Medical Director at St. Joseph Hospice—Baton Rouge.
"Dementia is accompanied by many challenges, with agitation and anxiety among the most frightening and frustrating for patients and families, and there are few options available to provide relief. This innovative study is driven by both the quest for new knowledge, as well as compassion for families dealing with dementia."
Hospice groups and end-of-life care providers in South Louisiana will be instrumental in connecting eligible patients with the study.
Provided by Pennington Biomedical Research Center