Partnership with Johns Hopkins and Harvard Affiliate Examines Impact of THC on Alzheimer’s-Related Agitation

February 5th, 2019
Marc E. Agronin, Senior Vice President for Behavioral Health and Chief Medical Officer for the Memory & Research Center at Miami Jewish Health, said clinical trials offer hope for the treatment of Alzheimer's disease, which is currently incurable.

Miami Jewish Health is partnering with Johns Hopkins University and McLean Hospital, an affiliate of Harvard Medical School, to test whether a known ingredient in cannabis will help reduce agitation in Alzheimer’s patients.

Recruitment for the placebo-controlled, randomized, double-blind clinical trial of the FDA-approved drug Dronabinol is currently underway. Dronabinol contains THC, the principal psychoactive ingredient in marijuana. The drug is commonly used to treat appetite and weight loss in patients with HIV and cancer.

Miami Jewish Health will be enrolling approximately 20 patient volunteers from our skilled nursing facility for the three-week-long trial. 

“The whole point of research is to try to find newer and better treatments which can bring hope for individuals struggling with different aspects of Alzheimer’s disease,” said Marc E. Agronin, Senior Vice President for Behavioral Health and Chief Medical Officer for the Memory & Research Center at Miami Jewish Health.

Does a Key Ingredient in Cannabis Reduce Agitation in Alzheimer's Patients?

Ricardo Castañeda, Director of Clinical Research and Business Development at Miami Jewish Health, said the THC study will run in three-week increments.

Agitation associated with Alzheimer’s can include verbal and physical aggression and excessive movement. It can be extremely disruptive. This unpredictable condition can affect a patient’s ability to interact with family, caregivers and others they encounter. 

Such patients are difficult to manage without treatment, which is why this new clinical trial is so important, Agronin explained.

“It’s upsetting to see a loved one who already has cognitive impairment now lose control of their behaviors. It’s upsetting for them and it can be dangerous for them and others. It also makes caring for them more difficult and can increase the risk for injury,” he added. “This study offers a relatively safe option to normalize their behavior.”

If Dronabinol reduces Alzheimer’s-related agitation, doctors could potentially write off-label prescriptions for the medication to manage the condition, said Ricardo Castañeda, Director of Clinical Research and Business Development at Miami Jewish Health.

“This is a great opportunity for us to continue to partner with McLean Hospital and Johns Hopkins, two very prestigious academic research institutions. I think it adds validity to Miami Jewish Health when organizations like these want us to be part of their research,” Castañeda said. “They are academic research institutions whose main goal is to advance the science and provide alternatives.”

THC Study Marks Second Collaboration with Academia

 Miami Jewish Health is also partnering with Johns Hopkins University on a clinical trial for Alzheimer’s patients. Already in progress is a community study involving the use of the antidepressant Escitalopram to treat agitation. Participants in that study are not required to be in skilled nursing.

Antipsychotics are commonly used to reduce agitation but success has been “spotty” and a mortality risk is involved, according to a presentation by Johns Hopkins and Harvard. Antidepressants have produced mixed results, the study notes.

Because of that, researchers are hoping to find alternative treatments that are safer and more effective than the medications in current use.

For more information about ongoing clinical trials, call Miami Jewish Health’s research hotline at 305.514.8710.

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