A pilot study suggests dronabinol, a synthetic version of THC, the active ingredient in Cannabis sativa L (marijuana), may reduce agitation and lead to weight gain in patients with Alzheimer’s disease. The results were presented today at the annual meeting of the American Geriatrics Society.
“Our trial, although preliminary, suggests dronabinol may reduce agitation and improve appetite in patients with Alzheimer’s disease, when traditional therapies are not successful,” said Joshua Shua-Haim, M.D., lead investigator in the study and medical director of the Meridian Institute for Aging, a continuum of senior health programs and services in Central New Jersey affiliated with Meridian Health System. “In the study, dronabinol appeared to be safe and effective for these patients. The results point to a promising direction for future research.”
An estimated 4 million Americans have Alzheimer’s disease and the number will grow to 14 million by 2050, according to the Alzheimer’s Association. In addition to memory loss, patients often experience agitation, loss of body weight, depression and restlessness.
“It’s important to look at all the aspects of Alzheimer’s disease that contribute to quality of life for patients, family members and caregivers,” said Dr. Shua-Haim. “Agitation and weight loss are upsetting and stressful as the patient’s needs become ever more demanding.”
Agitation is the most frequently encountered type of behavioral disturbance associated with Alzheimer’s disease and affects an estimated 75 percent of people with the disease. Weight loss, a common problem in patients with Alzheimer’s disease, is a predictive factor of mortality. Weight loss may derive from the deterioration of patients’ cognitive abilities, resulting in an inability to recognize hunger and thirst.
Dronabinol, marketed under the trade name Marinol, is synthetic delta-9-tetrahydrocannabinol (delta-9-THC). Delta-9-THC also is a naturally occurring component of Cannabis sativa L (marijuana). Dronabinol has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of anorexia in patients with HIV/AIDS and for the treatment of nausea and vomiting associated with cancer chemotherapy.
The study examined nine patients (mean age = 82) residing in a dementia unit of an assisted living facility or a nursing home. All patients met the DMS-IV and NINCDS-ADRDA criteria for possible Alzheimer’s disease and, according to their family or caregivers, had unsatisfactory control of their agitation. The mini mental status examination (MMSE), a test used to measure a person’s basic cognitive skills, and an assessment of activities of daily living were used to evaluate patients at the launch of the study and at one month. Patients initially received 5 mg/day of dronabinol in two doses. The treatment was titrated up to a maximum of 10 mg/day. In addition, all patients were treated with atypical neuroleptics and at least four medications to control behavior.
Analysis at one month found significantly reduced agitation in six patients. The evaluation by caregivers considered behavior and functionality, as well as cognition, when determining the efficacy of the treatment. Three patients experienced an average increase on the MMSE of 1.2 points (baseline = 11). Functional improvement was observed in three patients. Prior to the study, all patients experienced weight loss due to anorexia. After treatment with dronabinol, all patients had gained weight. No adverse events, such as falls, syncope, seizures or exacerbation of agitation or depression, were reported as a result of treatment.