University of Maryland School of Medicine launches groundbreaking study on THC/CBD therapy for dementia-related agitation at end of life

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 burdensome side effects, including respiratory suppression, excessive sedation, and worsening confusion. This trial seeks to determine whether T2:C100 can more effectively reduce agitation than a placebo, potentially minimizing 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 seek 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. In order to ensure objective results, the study is double-blind: 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.

Enrollment Contact Information

Families interested in participating or learning more about the study can call or email:

The University of Maryland School of Medicine
Gerontology, Geriatrics & Palliative Medicine Division
(410)328-7849
LiBBY@som.umaryland.edu

Or visit www.LIBBYStudy.org to view more study locations.

The Alzheimer’s Clinical Trial Consortium (ACTC) is led by Paul Aisen, MD, Alzheimer’s Therapeutic Research Institute at the University of Southern California (USC), Ron Petersen, MD, of Mayo Clinic, and Reisa Sperling, MD of the Brigham and Women’s Hospital and Harvard. Jacobo Mintzer, MD, MBA, of the Medical College of South Carolina in Charleston and Brigid Reynolds of Georgetown University were awarded this grant from the National Institutes of Health, National Institute of Aging. The investigators report no conflicts of interest.

Alzheimer’s Clinical Trials Consortium (ACTC) is funded by a Cooperative Agreement from the National Institute on Aging and the National Institutes of Health. Cooperative Agreement number U24AG057437.

Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol (LiBBY)

Principal Investigators: Jacobo Mintzer, MD, MBA, and Brigid Reynolds, MSN, ANP-BC

NIA/NIH Grant #: R01 AG068324-01

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