The Pennington Biomedical Research Center has announced a new clinical trial to evaluate the potential of THC and CBD oils to reduce agitation in patients with Alzheimer's and other dementias, and is actively seeking candidates in the Baton Rouge area.
Dr. Jeff Keller, director of the Pennington Biomedical Research Center's Institute for Dementia Research and Prevention and professor of aging and neurodegeneration, will lead the clinical trials and research in Baton Rouge.
He called the trial “the most important study we've ever done.”
“The restlessness, anxiety and distress that often accompanies Alzheimer's disease and dementia can be frustrating and frightening for both patient and caregiver,” Keller says. “The presence of agitation is one of the leading causes of caregiver burnout.”
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If a candidate is eligible, Pennington will begin the 12-week study with that individual. At the baseline visit, participants will be randomly assigned to one of two study groups.
One group will receive the active study drug, which contains CBD and THC oil, and the other group will receive a placebo (an inactive, harmless substance used to compare the effectiveness of drugs in clinical trials).
The drug under study is a combination of THC and CBD oil, which is administered orally to patients.
The study is “double-blind,” meaning that neither patients nor doctors know whether participants have received the active drug.
The study will follow patients over 12 weeks with one screening visit, six in-person visits, and five phone assessments. The in-person visits will take place in participants' locations, not in Pennington.
For more than 30 months, federal, state and local agencies worked together to refine the details of the clinical trial to “make it easier on patients,” Keller said.
Keller hopes that one in-person visit, multiple in-home visits and telehealth will be all it takes to achieve this.
Pennington will begin clinical trials with Baton Rouge-area candidates in August and will continue evaluating candidates and accepting them into the study through the end of the year.
Before the study ends, participants will be given the opportunity to continue in the study in an “open-label extension.” In this post-study period, participants will be able to consciously take the active drug under study.
Are you a candidate?
To participate in a clinical trial, patients must meet all of the following criteria:
Are receiving or eligible for hospice care Have symptoms of agitation – speech, physical, or psychomotor (pacing, restlessness, fidgeting) Are 40 years of age or older Have a diagnosis of dementia Are willing and able to take the study treatment as directed Have a study partner or “loved one” who will stay with the patient throughout the duration of the study
Research details
The End-of-Life Benefits of Cannabidiol and Tetrahydrocannabinol, or LiBBY study, is the first nationwide study funded by the National Institute on Aging, a branch of the National Institutes of Health.
Pennington is the fourth facility approved to begin treatment with CBD and THC oil, but more Alzheimer's research centers across the country are expected to be added to the study in the coming days.
Pennington is working with hospice providers in Baton Rouge to reach out to potential candidates and their families, and Carpenter Health Network, a Baton Rouge-based hospice group, is helping Pennington find them.
“Dementia, especially when combined with agitation, can be frightening for patients and heartbreaking for caregivers who often suffer from burnout,” John Kirwan, executive director of Pennington Biomedical, said in a news release.
“Other studies have shown that THC can be useful in treating nausea after chemotherapy, and the LiBBY study is a practical next step in exploring the benefits of these compounds and offering hope to people facing this difficult challenge,” Kirwan said.
There are currently no medications or therapies approved by the Food and Drug Administration to treat agitation in dementia patients receiving end-of-life care, Keller said.
Keller hopes the study will pave the way for more THC and CBD testing in the future, both across the country and in Louisiana.
“If there's anyone out there who might be interested, please give us a call,” Keller said.
Hospice providers, patients, families, or groups interested in this study should contact Dr. Jeff Keller at jeffrey.keller@pbrc.edu or the Pennington Biomedical Research Center Clinic at (225) 763-3000 or clinicaltrials@pbrc.edu.
