Study on Cannabinoids for Dementia Agitation Shows Promise

Dennys Gonzalez initially felt uncertain when informed that his father could join a clinical trial investigating the use of medical cannabis for alleviating agitation in individuals with advanced dementia.

However, after participating in the trial, he found that his concerns were largely unfounded. The treatment, which involved combining THC and CBD, significantly reduced his father Emilio’s agitation and frustration, who is 87 years old.

“Before the trial, my dad would actually get aggressive if you would try to help him with something,” Mr. Gonzalez remarked. He added that the treatment made a remarkable difference.

Recent preliminary findings presented at the Alzheimer’s Association International Conference in London detailed that nearly 90 percent of the 120 patients in the trial experienced reduced agitation after 12 weeks. In contrast, fewer than a quarter of those receiving a placebo reported similar improvements.

Experts in the field interpreted these results as an indication that a carefully controlled cannabinoid treatment could effectively manage agitation, a common and distressing symptom of dementia. Notably, the study has yet to undergo peer review or publication.

“I was thrilled to see that because there’s a lot of suffering happening,” said Elizabeth Edgerly, a clinical psychologist and vice president of care and support for the Alzheimer’s Association. She pointed out that while the results require validation from larger studies, they “look really promising” for aiding individuals with advanced dementia.

Agitation can affect up to half of the patients with advanced dementia nearing the end of life, creating distress not only for the patients but also for their families and caregivers. Symptoms include vocal outbursts, hostility, and physical outbursts.

At present, many affected individuals are treated with medications such as antipsychotics and opioids, which can have limited effectiveness and serious side effects. Dr. Edgerly noted that these traditional medications sometimes induce confusion and sedation, potentially shortening patients’ lives. “Anything that’s effective and safer is a huge improvement over standard care,” she said.

Previous studies have hinted at the potential benefits of cannabinoids for agitation, although some have been inconclusive. Dr. Kevin Hill, an addiction psychiatry director who didn’t participate in this research, pointed out that the formulation used in the trial is not yet FDA-approved.

Dr. Hill had previously co-authored analyses indicating a lack of strong evidence for cannabinoids’ effectiveness for many conditions, alongside risks of side effects. Still, he has found dronabinol, an FDA-approved THC product, beneficial for some dementia patients. He described the new study as “carefully conducted” with “a very robust finding.”

Despite the excitement around these findings, Dr. Hill cautioned that cannabinoid treatments should be prescribed by experienced healthcare providers. “It’s exciting that this presents another option to treat agitation, but it doesn’t mean that people should be giving their parents medical marijuana,” he clarified.

Mr. Gonzalez, who works in real estate in Miami, shared his initial hesitations about the treatment. “When they tell you they’re going to put your dad on something based on marijuana, does that mean he’s going to be high all the time?” he wondered.

Researchers reassured him that the dosage of THC was too low to induce a high. Mr. Gonzalez noted that once his father started the treatment, “his behavior improved,” and he became more tolerant when interacting with others.

Recently, the FDA approved Auvelity, a drug originally for major depression, for use in addressing agitation in Alzheimer’s patients—the first non-antipsychotic medication granted such approval. Dr. Edgerly commented that the cannabinoid study was focused on a wider array of dementia types and involved participants either in hospice care or eligible for it, noting that conducting a randomized trial with such a vulnerable population was commendable.

The definition of hospice typically applies to patients expected to pass within six months; yet, Dr. Edgerly mentioned that this can vary for dementia patients due to unpredictable life expectancies.

The study, led by Dr. Jacobo Mintzer from the Medical University of South Carolina, was dedicated to a woman who struggled with agitation unresponsive to medications. Dr. Mintzer expressed the need for allowing people to face death with “calmness, dignity, and grace.”

Researchers prioritized sensitivity to the patients’ conditions while ensuring scientific rigor. Treatments were provided in homes or care facilities, accommodating an aging population, with an average participant age of 81. Patients receiving the treatment did not have to discontinue other medications, and the delivery method was designed for ease, using digestible oil forms.

This Phase 2 trial, smaller than later stages considered the most robust for evidence, took place across ten sites. More than half of the participants were women, with a diverse representation of Hispanic and Black individuals.

The treatment involved a cannabinoid oil developed through collaboration with a Canadian pharmaceutical company containing specific dosages of THC and CBD. Half of the group received a placebo, while the others received a calculated dosage over the trial period.

After two weeks, participants receiving treatment exhibited significantly lower scores on an agitation scale, with 84 percent showing improvement compared to 31 percent in the placebo group. By the end of the trial, the treatment group saw 87 percent improved versus 24 percent of the placebo group.

No major safety concerns arose from the treatment. Dr. Mintzer reported that while serious adverse events occurred in both groups, they were typical for the patient demographic and included infections and worsening dementia symptoms. Eight individuals in the treatment group and three in the placebo group passed away during the study.

Dr. Ryan Vandrey from Johns Hopkins University commended the study, asserting it supports findings from his own smaller trial involving Alzheimer’s patients. He described it as “a significant advancement” and emphasized the need for further research into cannabinoid treatments for agitation.

He added that medical cannabis should not be a first-line therapy and should be considered only when other treatments have proven ineffective or problematic. Patients are advised against obtaining it from unregulated sources to avoid potential contaminants.

Finally, Mr. Gonzalez expressed concern since the trial’s end; his father has returned to some previous behaviors like yelling and sleep disturbances. “It’s a shame they don’t still have that available,” he remarked. “It actually worked.”