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Dementia is a cruel disease, not only for the patient but everyone in their orbit. People with advanced dementia may become agitated and angry.

“Agitation in the later stages of life with dementia can be a devastating symptom for both participants and their loved ones and caregivers,” said Brigid Reynolds, Georgetown University faculty member and co-principal investigator of a new study for dementia patients.

But the go-to medications to treat agitation, such as narcotics, anti-psychotics and benzodiazepines, come with unpleasant side effects.

“Available treatments often have unwanted side effects like sedation, falls or itching. And they often don’t work to treat the agitation,” Reynolds said.

“We’re very aware of significant caregiver burden associated with agitation symptoms at the end of life. We’d like to find something to improve quality of life at the end of life,” Reynolds said.

Nicknamed the LiBBY Study, the trial will determine if an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) is effective in treating agitation in hospice-eligible participants with dementia. It will also evaluate whether or not the oral combination of THC and CBD can help to reduce potential side effects of medications typically used to calm patients.

“This is the first of its kind study,” Reynolds said. “This is the first time THC-CBD has been tested in this population.”

Seven visits

People age 40 and over who have dementia and agitation may be eligible for the LiBBY Study. “You don’t have to have severe dementia to be in this study,” Reynolds noted. But potential participants should be in hospice or be eligible for hospice. Her study team will help determine eligibility.

In this 12-week study, visits may take place at the participant’s residence. Each visit lasts from one to two hours. In between home visits, the study team will check in with the caregiver by phone.

The study is a randomized, double-blind trial, meaning that participants will be randomly assigned to take a digestible oil that is either THC-CBD or a placebo. At the end of 12 weeks, all study participants are invited to participate in a 12-week extension without the chance of getting the placebo.

The LiBBY Study is funded by the National Institutes of Health’s National Institute on Aging and coordinated by the Alzheimer’s Clinical Trials Consortium.

There are 13 clinical trial sites that are enrolling participants in the LiBBY study, including the University of Maryland School of Medicine, Howard University and Medstar Georgetown University Hospital.

For more information, see libbystudy.org or contact the Memory Disorders Program a Georgetown University at leah.pulinat@georgetown.edu or (202) 687-9078.