09 Sep 2024 — An ongoing research at the US Pennington Biomedical Research Center is exploring the potential of THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) to reduce the feelings of agitation, distress and anxiety in patients with Alzheimer’s disease or other forms of dementia.
“The restlessness, anxiety and distress that frequently accompanies Alzheimer’s and dementia can be frustrating and frightening for both the patient and their caregivers,” comments Dr. Jeff Keller, who is the director of the Institute for Dementia Research & Prevention at Pennington Biomedical and a professor of aging and neurodegeneration.
The study titled “Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol,” or LiBBY, is the first such national-level study funded by the National Institute of Aging.
“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.”
Research design
The placebo-controlled, double-blinded study is designed for dementia patients experiencing agitation at the end-of-life stage who are either receiving hospice care or who are eligible for hospice. At present, there are no FDA-approved medications to treat this aspect of dementia.
As part of the study, participants will complete a baseline visit and will be randomly assigned to either a group receiving the active study drug or to one receiving a placebo.
The active study will take place over 12 weeks and will include one screening visit, six in-person visits and five evaluations by phone.
THC and CBD may provide relief for dementia-related anxiety.Before the end of the study, the participants will be able to request to continue their participation in the “Open Label Extension” portion of the study. At this stage, all participants will receive the active drug and not the placebo.
Pennington Biomedical facilitates the LiBBY study alongside 11 more research institutions. The research center is currently recruiting eligible participants alongside Georgetown University Medical Center, the University of Kentucky and the Ralph H. Johnson VA Medical Center.
The facility works with hospice care providers in the US Capital Region and beyond. The large hospice group Carpenter Health Network is one of the providers helping to identify patients and caretakers who may be eligible.
Raoul Manalac, medical director at St. Joseph Hospice — Baton Rouge, states: “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.”
Significance and implications
Manalac highlights that dementia is accompanied by many challenges, with agitation and anxiety in particular being among the most frightening and frustrating for patients and families. He says that 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.”
Dr. John Kirwan, executive director of Pennington Biomedical, adds: “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.”
“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.”
At the same time, a recent randomized trial of commercially sold cannabis products has found that CBD may be more effective in addressing anxiety than THC.
Another study revealed that CBG (cannabigerol) can reduce anxiety and stress without intoxication.
Meanwhile, in an interview with Nutrition Insight, the Consumer Healthcare Products Association called on the US FDA to improve its current regulation and guidelines for CBD products.