Georgetown Study Explores THC/CBD Combination to Reduce Dementia-related Agitation at the End of Life

Posted in News Release  |  Tagged Alzheimer's disease, brain, clinical trials, dementia, end of life care, Memory Disorders Program, mind, palliative care, research

First-of-a-kind clinical trial for hospice-eligible participants looks at the use of two components found in marijuana to help relieve agitation.

WASHINGTON (February 8, 2024) — In a first-of-its-kind clinical trial, the Georgetown University Medical Center Memory Disorders Program is studying the effects of an oral drug called T2:C100, which comprises two components found in marijuana — THC and CBD. The goal of the study is to investigate its potential to decrease agitation experienced by those with dementia at the end of life.

Commonly used medications for agitation in dementia at the end of life, such as morphine, valium and haldol, have limited effectiveness and often cause undesirable side effects. Recognizing the urgent need for better treatment options, the Alzheimer’s Clinical Trials Consortium (ACTC) Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol (LiBBY) trial aims to improve the quality of life and death for participants by exploring the potential of T2:C100. The ACTC LiBBY study will also examine whether T2:C100 will reduce the need for commonly used anti-agitation medications.

“This study is important because there are no FDA-approved medications to manage agitation at the end of life in dementia,” said Melanie Chadwick, the principal research investigator for Georgetown’s Memory Disorders Program. “Over 50 percent of people with dementia will receive hospice care at the end of life; 70 percent of them will receive psychotropic medications for the management of agitation. However, these medications often cause unwanted side effects.”

“We’re testing a new treatment for a condition that’s common and often devastating,” said Brigid Reynolds, a Georgetown University faculty member and national co-principal investigator of the study. “We hope physicians and caregivers will be interested in helping to enroll participants in this trial, as the benefits could be significant. This effort may lead to even larger trials that could expand our knowledge of the possibilities of this potential new treatment.”

Participants in this 12-week, phase 2 trial will be assigned randomly to receive either a placebo or the active study drug. To reduce bias in reporting of symptoms, neither the participants nor the clinician will know which is being administered. Georgetown is recruiting people near the end of life in the DMV area. Each study visit will occur at participants’ places of residence. It is one of approximately 10 sites nationwide participating in the NIH-sponsored ACTC LiBBY trial (ClinicalTrials.gov ID NCT05644262).

The majority of participants in the trial are expected to demonstrate fluctuations in consciousness as part of the dying process. Therefore, family members, partners and professional caregivers will be providing hands-on care under the guidance of palliative and hospice care teams. These partners will play a vital role in administering the study medication and will be reporting on participants’ agitation and other behavioral symptoms. The LiBBY study will also examine caregivers’ experiences in assisting persons with agitation and dementia at the end of life.

“The Georgetown University Memory Disorders Program started over 20 years ago and is unique to Washington D.C.,” says Chadwick. “We have extensive experience in conducting clinical trials of potential new treatments for Alzheimer’s disease and related disorders.”

Family members interested in the clinical trial should call or email Leah Pulinat at 202-687-9078 or leah.pulinat@georgetown.edu .

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