A new clinical trial will investigate the potential of cannabis-based treatment to improve quality of care for hospice eligible patients with dementia.
The University of Maryland School of Medicine (UMSOM) Palliative Medicine Program has launched a new clinical trial funded by the National Institute on Aging to explore a potential treatment for agitation in patients with dementia nearing the end of life.
The study focuses on an investigational oral drug, T2:C100, which contains the two active ingredients in cannabis: THC and CBD.
Currently, standard medications such as morphine, valium, and Haldol are commonly used to manage agitation in hospice-eligible patients with dementia. However, these treatments are often ineffective or associated with side effects, including respiratory suppression, excessive sedation, and worsening confusion.
The trial seeks to determine whether T2:C100 can more effectively reduce agitation than a placebo, potentially minimising reliance on these medications while enhancing patient comfort and quality of care.
“This study is important because there are no FDA-approved medications to manage agitation at the end of life in dementia,” said Raya Kheirbek, MD, Principal Investigator and Division Chief of Geriatrics and Palliative Medicine at UMSOM and UMMC.
“More than half of people with dementia will receive hospice care, and 70% of them are given psychotropic medications to manage agitation — often with limited benefit and problematic side effects.”
Researchers are looking to recruit a total of 120 participants who will be randomly assigned to take either T2:C100 or a placebo twice a day for 12 weeks.
The study is double-blind, meaning neither participants nor clinicians will know which treatment is being administered. After 12 weeks, all participants will be given the option to continue participation for an additional 12 weeks on T2:C100.
UMSOM is one of 13 national trial sites involved in this study, which is listed on ClinicalTrials.gov. The trial will be conducted in the General Clinical Research Center at UMSOM.
“We’re testing a potential treatment for a condition that’s not only common but incredibly distressing,” said Dr Jacobo Mintzer, Principal Investigator, professor at the Medical University of South Carolina (MUSC) and staff physician at the Ralph H. Johnson VA Health Care System.
“Our hope is that clinicians and caregivers will consider enrolling eligible patients. Success in this trial could open the door to larger studies and wider treatment availability.”
The clinical trial is part of the NIH-sponsored Alzheimer’s Clinical Trials Consortium (ACTC) and titled the Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol (LiBBY) Study.
A number of studies have examined whether cannabis could be used to treat some of the symptoms of the disease, such as easing aggression, agitation and anxiety, which are commonly seen among patients. In a 2022 review researchers concluded that there is ‘strong evidence’ to support the idea that cannabinoids have neuroprotective properties and could have a role in treating common neurodegenerative diseases, including Alzheimer’s.
More recently, an eight-year clinical trial, led by the Johns Hopkins University School of Medicine and Tufts University School of Medicine, previously found that a pill form of the drug dronabinol, an FDA-approved synthetic version of THC, reduces agitation in patients with Alzheimer’s by an average of 30%.
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