In a groundbreaking study conducted by the Johns Hopkins University School of Medicine and Tufts University School of Medicine, researchers have discovered that a pill form of dronabinol, an FDA-approved synthetic version of THC, the primary ingredient in marijuana, can significantly reduce agitation in patients with Alzheimer’s disease by an average of 30%.
The researchers found that when compared to currently available treatments for agitation, such as antipsychotics, dronabinol produced similar calming effects without the negative side effects of delirium or seizures.
Presented at the International Psychogeriatric Association conference in Buenos Aires, Argentina, on Sept. 26, the results of this eight-year clinical trial represent a significant advancement in the treatment of Alzheimer’s-related agitation. “These new findings are a result of eight years of dedicated work to improve the lives of those with Alzheimer’s and their caregivers,” says Dr. Paul Rosenberg, professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and co-principal investigator of the study.
Alzheimer’s disease is a prevalent neurodegenerative disease in the United States, with an estimated 6.7 million cases in Americans aged 65 and older, a number projected to rise to 13.8 million by 2060. Agitation is a challenging symptom to manage, characterized by excessive motor activity, verbal aggression, and physical aggression. Approximately 40% of individuals with Alzheimer’s develop agitation.
While behavioral interventions may help with mild agitation, moderate to severe cases often require medication to manage symptoms and provide relief for caregivers. “It is often the agitation, rather than the memory loss, that drives individuals with dementia to seek emergency care and long-term care facilities,” says Dr. Brent Forester, psychiatrist-in-chief and chairman of the Department of Psychiatry at Tufts Medical Center and co-principal investigator of the study.
In the study, 75 patients with severe Alzheimer’s agitation across five clinical sites, including The Johns Hopkins Hospital, were recruited. Patients had a clinical diagnosis of Alzheimer’s and exhibited at least one major symptom of agitation for at least two weeks. Baseline agitation scores were measured using the Pittsburgh Agitation Scale and the Neuropsychiatric Inventory Agitation/Aggression subscale.
Participants were randomly assigned to receive either 5 milligrams of dronabinol or a placebo twice daily for three weeks. After three weeks, the dronabinol group showed a 30% decrease in agitation compared to the placebo group, which showed no change. Dronabinol was well tolerated by patients and showed promise as an effective treatment for Alzheimer’s-related agitation.
Researchers plan to conduct longer-term studies on the use of dronabinol for Alzheimer’s disease with larger sample sizes. They also hope to explore additional ways in which medical cannabis can benefit both patients and caregivers.
Dronabinol, a synthetic form of THC, was approved by the FDA in 1985 for treating appetite loss in patients with HIV/AIDS and is currently used to manage nausea and vomiting in cancer patients undergoing chemotherapy.
While the study results are promising, the researchers caution against using other forms of medical marijuana available in various states without proper research and guidance. The study was funded by a grant from the National Institute of Aging at the NIH.
