An FDA-approved synthetic version of THC (the main ingredient in cannabis) reduces agitation in patients with Alzheimer’s disease by an average of 30 percent, according to the results of an eight-year clinical trial.
Compared to current treatments like antipsychotics, the synthetic drug dronabinol produced similar calming effects without adverse results such as delirium or seizures.
The results of the research were presented at the International Psychogeriatric Association conference in Buenos Aires, Argentina.
Agitation in Alzheimer’s patients
Dr. Paul Rosenberg is a professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and co-principal investigator for this study.
“These new findings represent eight years of work dedicated to people who have Alzheimer’s as well as their caregivers,” said Dr. Rosenberg.
“Agitation is one of the most distressing symptoms of Alzheimer’s dementia, and we are pleased to make positive strides forward in treatment of these patients.”
Severe agitation with Alzheimer’s
Alzheimer’s disease is the most common neurodegenerative disease in the United States, affecting an estimated 6.7 million Americans aged 65 and older. This number is predicted to grow to 13.8 million by 2060.
Agitation, characterized by excessive motor activity (like pacing or repetitive movements), verbal aggression, and physical aggression, affects approximately 40% of people with Alzheimer’s and is difficult to manage.
Providing relief to caregivers
Although mild agitation can sometimes be moderated by behavioral interventions, moderate to severe cases typically require medication to manage symptoms and provide relief for caregivers.
Dr. Brent Forester is the chairman of the Department of Psychiatry at Tufts Medical Center and co-principal investigator on the study.
“It is the agitation, not the memory loss, that often drives individuals with dementia to the emergency department and long-term-care facilities,” said Dr. Forester.
“Dronabinol has the potential to both reduce health care costs and make an important, positive impact on caregivers’ mental and physical health.”
Focus of the clinical studies
For the clinical trials, the researchers recruited 75 patients with severe Alzheimer’s agitation across five sites, including 35 patients admitted to the Johns Hopkins Hospital between March 2017 and May 2024.
To qualify, patients had to have a formal clinical diagnosis of Alzheimer’s disease and exhibit at least one major symptom of agitation for at least two weeks. Prior to treatment, patients were tested for agitation using the Pittsburgh Agitation Scale (PAS) and the Neuropsychiatric Inventory Agitation/Aggression subscale (NPI-C).
Participants were randomly assigned to receive either five milligrams of dronabinol in pill form or a placebo twice daily for three weeks.
Synthetic cannabis and Alzheimer’s
After the treatment period, patients were retested using the PAS and NPI-C. The results from the dronabinol group showed an average PAS starting value of 9.68 and an end value of 7.26 after three weeks – a 30% decrease – compared to the placebo group, which did not change.
Additionally, the synthetic cannabis was well tolerated by Alzheimer’s patients compared to current treatments for agitation.
“Results like this are encouraging. We are thrilled that FDA-approved dronabinol was robustly effective and appeared safe for treatment of agitation,” Rosenberg said. “This adds another tool in our efforts to improve the care of our loved ones with Alzheimer’s disease.”
Future research directions
The researchers plan to conduct longer-term studies of dronabinol for Alzheimer’s disease with larger sample sizes. They also hope to explore other ways medical cannabis can benefit both patients and caregivers.
Dronabinol is a synthetic form of THC, the psychoactive main ingredient in cannabis (marijuana). The drug was approved by the U.S. Food and Drug Administration in 1985 to treat loss of appetite in patients with HIV/AIDS and is currently prescribed to treat nausea and vomiting in those undergoing cancer chemotherapy.
The investigators caution that the results of their current study are not intended to encourage or inform the use of other forms of medical marijuana, which are available in 38 states and the District of Columbia.
H/T: www.earth.com
