The first major drug efficacy trial will begin soon in the UK to test the effects of cannabis medication for treating certain symptoms of dementia.
Scientists at Kings College London will be testing Sativex, the world’s first plant-derived cannabinoid prescription drug. Sativex (nabiximols) is produced by British pharmaceutical company GW Pharmaceuticals and is a 1:1 ratio of THC to CBD, two well-known and important marijuana cannabinoids.
The drug, a peppermint-flavored mouth spray, has been approved in 28 countries for the treatment of muscle spasticity that accompanies multiple sclerosis (MS), but is currently not licensed for any indication other than MS.
British scientists have preliminary evidence that Sativex might also be able to reduce some of the aggression and agitation that many dementia patients experience.
Dementia actually refers to a very broad category of brain diseases associated with a gradual decrease in the ability to remember. Many dementia patients also have language difficulties, communication difficulties, affected reasoning and emotional problems. Patients typically have a greater decline than what is normally experienced with mere aging and the symptoms make it very difficult to perform even the simplest of daily tasks.
Alzheimer’s disease causes the majority of dementia cases. As the disease progresses, patients often experience increased agitation, restlessness, emotional distress and verbal or physical outbursts. Dementia is a significant cause of both patient and caregiver stress.
In the UK, around 850,000 people have dementia, and about half experience these symptoms as well as confusion and memory loss. In a decade, the UK projects it will have over one million dementia cases, and in America now, there are more than three million diagnosed cases of dementia every year.
Britain’s National Health Service will recruit pensioners (retirees living in nursing homes) who have Alzheimer’s and dementia symptoms to participate in the study. The team plans to recruit 60 patient volunteers aged 55 to 90.
GW Pharmaceuticals has been conducting cannabinoid research for over 20 years. The company primarily focuses on central nervous system (CNS) disorders like epilepsy, and has developed a number of plant-derived cannabinoid therapeutics, including Sativex and their newest drug, Epidiolex, a plant-derived highly concentrated form of cannabidiol (CBD). Epidiolex recently received U.S. Food and Drug Administration (FDA) approval for use in patients with severe, rare and difficult-to-treat forms of intractable epilepsy — Dravet syndrome and Lennox-Gastaut syndrome. After the June 2018 FDA approval, GW launched the drug in the U.S. in November 2018, and it is now available for prescription use.
Alzheimer’s Research UK has committed £300,000 funding to trial. The volunteers will take Sativex or a placebo for four weeks, then results will be compared. Lead researcher Dag Aarsland explained that even though most people associate Alzheimer’s disease with memory loss, the affliction is a very complex condition that can affect individual patients in several different ways. Aarsland explains that many of them become agitated or even aggressive.
There are very few real treatments for the psychiatric and behavioral symptoms that accompany dementia. There is no cure for either Alzheimer’s or dementia – just medications to treat the symptoms.
Aarsland explained that drug alternatives are desperately needed because anti-psychotic drugs are the standard course. While these drugs help some patients, they also have very serious side effects. In fact, it has been 15 years since the development of any new dementia treatments (the drug Memantine in 2002/2003), so the researchers hope the trial sheds light on a possible viable alternative.
Most of the focus of dementia research is for the development of drugs to slow down or stop the progression of diseases that cause dementia. With this trial, Sativex potentially offers a medication that benefits people in their daily battle against the behavioral symptoms of dementia. If successful, the research team will conduct a much larger study.
The Sativex trial will be a Phase 2 trial, meaning that at the outset, the drug is not expected to have any effect on dementia. Researchers will test the drug on patients to determine its efficacy, side effects, and practicality at administering it as a mouth spray, its current formulation.
Alzheimer’s research does not have a good success story. In clinical trials conducted between 2002 to 2012, nearly all (99.6%) failed. The Alzheimer’s Research UK chief science officer David Reynolds explained that the Sativex testing is vital because a wide range of approaches should be considered to help people effectively manage and live with the disease.
Canadian researchers have also studied cannabis’ effect on aggression and agitation. In particular, they have studied Nabilone, a synthetic cannabinoid originally developed for nausea and vomiting that accompanies chemotherapy. In Canada, Nabilone is widely used to treat chronic pain, and the country has also conducted trials looking at Nabilone’s effectiveness for MS and fibromyalgia.
A team at the University of Toronto presented results of a randomized, double-blind clinical trial in September 2018 indicating that the synthetic cannabinoid may effectively treat agitation in people with Alzheimer’s disease.Return to All Conditions
Data last updated 12/03/2019