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Oral Cannabis Spray Sativex to Be Tested on Dementia Patients in Major Trial

By | May 15th, 2019

This fall, researchers at King’s College in London will test medical marijuana on patients with dementia to determine whether the drug will help treat symptoms like agitation and aggression. The team will use Sativex, an oral spray that contains THC and CBD. Lead researcher Chris Albertyn said they hope the drug can be used as an alternative to antipsychotic medications that are used to treat aggression in those with dementia, but often come with dangerous side effects. Previously, Sativex was approved to treat patients with multiple sclerosis (MS) and alleviate joint pain. Albertyn said that though the trial is currently aimed at UK residents, the researchers hope to conduct multinational studies testing Sativex on dementia patients if the results of the pilot study seem promising.

  • Sativex contains about 2.5 milligrams of THC and 2.5 milligrams of CBD
  • The pilot study will begin in September, 2019 and include 60 participants from UK nursing homes 
  • The majority of participants will be in the later stages of dementia

Being Patient spoke to Albertyn about how Sativex may help those living with dementia, the upcoming trial and future research on Sativex and dementia. 

Using Sativex to Treat Agitation and Aggression in Dementia Patients

Being Patient: Can you tell us more about Sativex?

Chris Albertyn: It’s administered as an oral spray. It’s actually licensed in the US as well as the EU, but for multiple sclerosis. We’re looking to repurpose it and investigate this activity in dementia, specifically for symptoms of agitation and aggression.

Being Patient: When Sativex was used on patients with MS, it was found to be very effective. Is that correct?

Chris Albertyn: Yes, it really helps to target those joint and musculoskeletal issues and reduce joint pain by loosening things up.

Being Patient: Why did researchers believe Sativex may help dementia patients?

Chris Albertyn: When a patient has been very confused and out of sorts—not really aware of where they are—it’s understandable they could get agitated and perhaps aggressive. That’s the symptom we’re trying to target. Currently, there’s a scarcity of pharmacological treatments out there and some of them are dangerous, especially in the long-term, so they would prescribe off-label antipsychotics for the more severe cases of agitation. That comes with adverse health outcomes for the individual, as well an economic impact on hospitals. We’re looking for a safer but just as effective, if not more effective, alternative. We’re not the only ones who have explored the utility of cannabis in this area. You’ve covered a Canadian research team and I believe there’s a team at Johns Hopkins that has done some research in this area, so it’s growing internationally, but they’re all pilot studies. They’re looking very promising. We’re excited about the potential of this area, so the small but promising studies have shown estimated efficacy for agitation in dementia.

Being Patient: What is the concentration of CBD and THC in Sativex? What do we know about how CBD versus THC impact behavior?

Chris Albertyn: THC and CBD are known as cannabinoids. They’re part of a wide array of compounds that come from the cannabis plants, just two of hundreds actually, but they’re the two main ones that we know of. THC is the psychoactive compound. It’s the one where you get that subjective high feeling, but it’s also been found as the compound that most reliably induces a therapeutic effect.

There has also been a growing interest in CBD. The concentrations of the dose are very important when referring to cannabinoid compounds, and a lot of lab scientists are looking into that. You only need 2.5 or 5 milligrams of THC to have an effect, but you need in the hundreds of CBD to achieve a therapeutic effect.

With Sativex, it’s a one-to-one concoction so we’ve got half CBD and half THC. It’s administered through an oral spray so it’s a spray into the mouth; it’s not inhaled, ingested or swallowed so that’s a highly innovative method, particularly in the dementia population, that we’re excited to explore. In each one of those sprays, you get about 2.5 milligrams of THC and 2.5 milligrams of CBD. It’s important to note that the CBD isn’t actually having a therapeutic effect in itself. It’s augmenting and working synergistically with the THC component.

Being Patient: Many caregivers mention that their loved ones have been placed on antipsychotics to treat agitation, causing them to experience negative side effects. Are there any known side effects from Sativex? 

Chris Albertyn: With any compound, you have to be realistic about the risk versus benefit ratio and that’s really down to the clinician doing the prescribing to make that decision.

In comparison to other antipsychotics, with Sativex, it’s a relatively innocuous substance so we’re looking at side effects along the lines of increased dizziness, dry mouth, which is a common one, and then just a risk of increased falls, particularly in an elderly population. You wouldn’t want to necessarily administer it to someone with severe cardiac issues or a history of cardiac disease.

Thankfully, because it’s already a licensed drug and it’s gone through that rigorous and objective safety profiling assessment, we have a much better awareness of what the physiological risks are. For instance, as part of this trial, we are able to look at the summary of characteristics and contraindications and then pre-screen for these, so any sort of drug-to-drug interactions that we’re worried about or any history of cardiac disease or significant psychiatric illness. If there’s a history of significant psychosis or depression, then we will screen for that and exclude those participants. That’s something that would happen in practice as well.

One of the First Trials Testing Medical Marijuana on Dementia Patients

Being Patient: The trial is starting in September of 2019. Is that correct? How extensive will the study be and how long will it take to determine whether there is an effect? 

Chris Albertyn: That is correct. The study itself will run for just over a year, I think about 15 months, where we’re collecting data and recruiting participants. Our aim as clinical academics is to get the information out there as soon as possible. Within a few months of finishing the trial, we’re having to publish and inform other scientists and clinicians as well as the public about the results of the study with the aim being able to then move on to a larger trial where we could really look at the efficacy. This is just a pilot study at the moment. We’re looking at the feasibility and  acceptability of the treatment, whether or not it’s good practice and helpful. Then we can have an estimate of the efficacy following this trial.

Being Patient: How many people will be enrolled in the initial pilot study? 

Chris Albertyn: We’ve got 60 people. We’re using a randomized control design with a placebo so 30 people will be on the treatment and 30 people on the placebo so we can really get a good direct comparison. The resident won’t know which they’re on and neither will the researchers, which increases the power of the study so there’s no bias.

Being Patient: Why is Sativex targeting behavior rather than memory? 

Chris Albertyn: When you look at the effect of cannabis consumption, you discover its impact includes increased drowsiness, a calm, relaxed feeling, and you associate those with a therapeutic potential in a behavioral sense. When you’re talking about the pathology of various types of dementia, there have been some exciting lab results about targeting some of the underlying causes of dementia, but it’s been really difficult. Translating it to in-person studies has not been successful. So it’s an exciting avenue for the future, considering that cannabis is in this societal shift and more people are focusing on it. Hopefully more funding goes into the research. I’m excited to see what we can find.

Being Patient: Is it possible for people to still join this study?

Chris Albertyn: At the moment, we’re just in the set-up stage and unfortunately, it is just a UK-centric study, specifically closer to London if possible because our research team has to travel to these nursing homes to conduct the assessments and bring the drug to the nurses. It’s local for the time being. I am hopeful that if there are promising results, we can do a multinational study to look at the impact across the world in Canada, the United States, Australia and so on. This autumn, we’ll have confirmed participant information sheets and materials to send out.

Being Patient: Are you targeting a specific age group? 

Chris Albertyn: We want to make sure we’re conducting this experiment in a controlled, measured setting where we can be careful about any potential risks, especially because cannabis is such a buzz word. If anything goes wrong from one cannabis medication and it seemed to be irresponsibly used, that could affect a lot of future work and attention to its therapeutic potential. When it comes to age, we wanted to be as inclusive as possible. We chose nursing homes because a trained clinician can administer the drug and the impact can be monitored. But we’ll look at people of any age in a nursing home and they’re likely to have more severe dementia. We’ve put an age cap at 90, which was a subject of debate because in human studies, the highest age was up to 90 and that’s in the summary of the Sativex product characteristics. I think it could go beyond, but just to be safe, we wanted to keep it within that bracket.

There are a couple of studies in the pipeline where we’re hoping to recruit participants from the community, but it’s much harder to monitor the risks and compliance of how often the drug is taken. That’s a future step because we want to expand the therapeutic potential across the board so it can be accessed by everyone who may need it.

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