The health center starts the clinical trial of a drug that could improve the cognitive function of this group
A new clinical trial will seek to validate the safety and tolerability of a new medication for cognitive improvement of people with Down’s Syndrome. It would be the first drug for this group, which until now had been “orphaned by medication”. The Institut Hospital del Mar for Medical Research (IMIM-Hospital del Mar) has just launched this study, which will be the first to analyze the feasibility of a new type of approach in this field. For this, the hospital seeks 45 people between the ages of 18 and 35 with Down syndrome to participate in this clinical trial. The results of the investigation will be known in spring.
This medication is intended for “cognitive enhancement” of the brain of people with Down syndrome, so that they have “better life quality“. The drug is based on the modulation of the functioning of the endocannabinoid system of the brain. According to various studies, people with Down syndrome have hyperactivity of the CB1 cannabinoid receptor, and its modulation with specific inhibitors drastically improves cognitive performance in animal models. Based on this principle, the French company Aelis Farma has developed an innovative approach, through a new molecule called AF0217, the first of its kind, which works by imitating a natural defense mechanism in the brain to counteract the hyperactivity of this receptor.
Also for autism and ADHD
“With this study we will not only demonstrate that the treatment is safe and well tolerated by people with Down syndrome, but we will have tools to monitor if the treatment has positive effects in the cognition of these people”, says Dr. Rafael de la Torre, who will lead the clinical trial. De la Torre points out that this drug, if it proves effective, could also be useful in autism spectrum disorder or attention deficit disorder and hyperactivity (ADHD).
The 45 volunteers participating in the study will be divided between those who will take the drug (an oral solution that is swallowed with water) and those who will receive a placebo. They will do it for 28 days, during which time monitoring will be done. Before starting it and at the end, they will undergo cognitive performance tests and an encephalogram to have a first view of how the treatment affects their cognitive abilities.
Once the results of this phase have been obtained, a new study will be proposed, this time with various centers throughout Europe and with a greater number of volunteers (150). The intention of the driving team is to launch this European study next summer. The goal of the researchers is to get a treatment that improves memory of work of these people, a key cognitive deficit in this pathology.