MGC Pharmaceuticals | 22 October 2018
The second study is an investigator-sponsored, 160-patient Phase II pilot study of dronabinol for
the treatment of agitation in AD (NCT02792257). The trial, which commenced in March 2017, is
expected to report top-line results in August 2020. Dronabinol (Marinol, AbbVie), a synthetic oral
formulation of THC, is FDA-approved for anorexia/weight loss in AIDS and for nausea/vomiting
associated with chemotherapy.
The successful nabilone study and the ongoing studies of dronabinol and Avidekel raise the
possibility that CogniCann could face competition from an established cannabinoid-based therapy
for dementia-related AD symptoms by the time MGC generates efficacy data for CogniCann for this
Other potential drugs for agitation in dementia on the horizon
Neither the FDA nor EMA has approved any drugs to treat neuropsychiatric symptoms such as
agitation in dementia patients. Non-pharmacological interventions are suggested as first-line
treatment, but are not effective for every patient. Currently, these symptoms are treated by off-label
use of psychotropic medications such as antipsychotics, antidepressants, benzodiazepine
sedatives and anti-convulsants. These drugs have modest efficacy and their use can produce
harmful side effects.
A number of candidate drugs are in Phase III development for the treatment of agitation in
dementia, including the antipsychotic brexpiprazole, the antidepressant citalopram, and the novel
compounds AVP-786 (deuterated-dextromethorphan/quinidine combination) and Lumateperone
These drugs could be potential competitors for CogniCann (if approved).
The Alzheimer’s disease and dementia market
A recent meta-analysis found that the prevalence of dementia worldwide for people aged 60 years
or older ranged from 5-7%; the prevalence in the US was 6.5% while in Western Europe it was
Dementia is estimated to affect 50 million people worldwide currently, with the number
expected to triple to 152 million by 2050. About two-thirds of dementia patients have AD; other
common dementia syndromes include vascular dementia, mixed dementia, Lewy body dementia or
frontotemporal degeneration.
Over 90% of people with dementia experience at least one neuropsychiatric symptom over the
course of their disease. Agitation, psychosis and mood disorders are the three main
neuropsychiatric syndromes of dementia. Agitation (including aggression and non-aggressive
agitation) occur in 20% of people with AD living in the community and in 40-60% of individuals with
dementia living in care facilities.
As we do not have data on the proportion of dementia patients living in care facilities, we
conservatively assume that the addressable market of patients with agitation or other
neuropsychiatric symptoms that are not adequately controlled by non-pharmacological interventions
represents 10% of dementia patients. This represents 550,000 patients in North America, 950,000
patients in Central and Western Europe and 40,000 patients in Australia.
The market research group EvaluatePharma estimated that the market for AD drugs was valued at
~US$2.4bn in 2018 and forecasts it to grow to US$5.7bn by 2024. The approved AD drugs fall into
two drug classes. Cholinesterase inhibitors, such as donepezil, galantamine and rivastigmine, slow
down the breakdown of the neurotransmitter acetyl choline, which is involved in memory and
Porsteinsson et al 2017. Expert Opinion on Pharmacotherapy, 18:6, 611-620
Prince et al 2013. Alzheimers Dement. Jan;9(1):63-75
World Alzheimer Report 2018
Ballard and Corbett 2010. CNS Drugs 2010; 24 (9): 729-739