Synthetic THC (dronabinol) was well tolerated by patients without adverse effects often seen from current Alzheimer’s agitation medications
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A recent study led by researchers from Johns Hopkins University School of Medicine and Tufts University School of Medicine has shown that dronabinol, a synthetic version of THC (the main ingredient in marijuana), can reduce agitation in Alzheimer’s patients by an average of 30%. Dronabinol is an FDA-approved medication in pill form.
The study suggests that dronabinol may be as effective as current treatments for agitation, such as antipsychotic medications, but with fewer negative side effects like delirium or seizures. These findings were shared at the International Psychogeriatric Association conference in Buenos Aires on September 26th.
“This represents eight years of work dedicated to people who have Alzheimer’s as well as their caregivers,” said Paul Rosenberg, M.D., professor of psychiatry and behavioral sciences at Johns Hopkins and co-lead investigator. “Agitation is one of the most distressing symptoms of Alzheimer’s dementia, and we are pleased to make positive strides forward in treating these patients.”
Alzheimer’s disease is the most common neurodegenerative disease in the U.S., affecting an estimated 6.7 million Americans aged 65 and older. This number is expected to nearly double by 2060, according to the National Institutes of Health. About 40% of Alzheimer’s patients develop agitation, which is characterized by excessive motor activity, verbal or physical aggression, or repetitive movements. Managing agitation is challenging, especially in moderate to severe cases, where medication is often necessary to relieve patients and caregivers.
Brent Forester, M.D., psychiatrist-in-chief at Tufts Medical Center and co-principal investigator, noted that agitation, not memory loss, is often what drives dementia patients to emergency rooms and long-term care facilities. “Dronabinol has the potential to both reduce health care costs and make an important, positive impact on caregivers’ mental and physical health,” Forester said.
For this study, 75 patients with severe Alzheimer’s-related agitation were recruited across five clinical sites, with 35 of them admitted to The Johns Hopkins Hospital. To qualify, patients needed a formal Alzheimer’s diagnosis and had to show at least one significant symptom of agitation for at least two weeks.
Participants were randomly assigned to receive either 5 milligrams of dronabinol or a placebo twice daily for three weeks. Their agitation levels were measured using two scales: the Pittsburgh Agitation Scale (PAS) and the Neuropsychiatric Inventory Agitation/Aggression subscale (NPI-C). Before the treatment, the average PAS score for the dronabinol group was 9.68. After three weeks, that score dropped to 7.26—a 30% reduction. The placebo group’s scores remained unchanged.
“We are thrilled that FDA-approved dronabinol was robustly effective and appeared safe for treating agitation,” Rosenberg said. “This adds another tool in our efforts to improve the care of our loved ones with Alzheimer’s disease.”
The researchers plan to conduct longer-term studies with larger sample sizes to further explore the potential of dronabinol in Alzheimer’s treatment. They are also interested in investigating other ways medical cannabis could benefit both Alzheimer’s patients and their caregivers.
Dronabinol is a synthetic form of THC, the psychoactive ingredient in cannabis. The FDA first approved the drug in 1985 to treat appetite loss in HIV/AIDS patients and later to treat nausea and vomiting in cancer patients undergoing chemotherapy.
The researchers emphasized that their study is not meant to promote or encourage the use of other forms of medical marijuana, which are currently available in 38 states and Washington, D.C.
This study involved a number of co-investigators, including Halima Amjad, Haroon Burhanullah, and Milap Nowrangi from Johns Hopkins, Marc Agronin from Miami Jewish Health, and James Wilkins and David Harper from McLean Hospital.
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