Alzheimer’s: Cuba takes a new step with promising development | Nasal medicine for mild or moderate conditions is in the third phase

Cuba is back in the news because of its scientists. The island, which immunized its entire population using its own formulations during the pandemic, says the drug to treat mild to moderate Alzheimer’s disease is in Phase III and could benefit 47 million people if its safety and efficacy are confirmed. A world affected by this neurodegenerative disease. The project, coordinated from the Center for Molecular Immunology, is moving at full speed and interim results are expected in the coming months. The president, Miguel Díaz-Canel Bermúdez, communicated through his Twitter account: “A new challenge and a new contribution from Cuban science.” If all goes as expected, it could even be used to treat people with ataxias, Parkinson’s and cardiovascular diseases.

Easy to use nasal application drops called Caribbean medicine “NeuralCIM”. The breakthrough was spurred by a practical problem: On the island, one in 10 people over 65 has been diagnosed with Alzheimer’s disease. Therefore, the laboratory’s response promises to contribute to combating a condition that affects memory, location and other mental functions, in the absence of effective treatments to halt its progression to date. There are only a few formulas that help to reduce the disease to some extent, but they are very expensive; On average, as calculated, the annual treatment will be worth 80 thousand dollars.

Alzheimer’s usually appears after age 65 and develops in people over 80. It is a disorder that affects the communication and socialization of those who experience it, and it ultimately usually leads to distress and depression. Although the drug is not expected to stop dementia, This is expected to improve patients’ symptoms and slow the course of cognitive decline they experience. In a complementary way, it can also contribute to improving the quality of life of family members and caregivers.

Study, in two parts

In an effort to confirm its efficacy and safety in local populations from different latitudes, the research is being carried out in two parts. On the one hand, 413 patients will present themselves in ten centers distributed in Havana. In this case, the subjects participating in the trial will undergo not only clinical but also molecular studies for one and a half years. Along the same lines, some of the volunteers will also receive Donepezil, a drug already approved by the United States Food and Drug Administration (FDA) for Alzheimer’s disease.

The second phase will be carried out at institutions in other parts of the country and will recruit 1,456 people. In this case, the examination will be of a clinical nature in only one hospital in each province, except in Granma and Santiago de Cuba, where the examinations will be conducted by two hospitals in each case. total, The process and evaluation of results is estimated to take two years.

In all trials, the molecule that works and the scientific team is testing is called NeuroEPO, a nasal formulation of recombinant human erythropoietin (EPO). It is expected to have anti-inflammatory effects, increase blood flow, be an antioxidant, and stimulate the formation of new blood vessels.

“It is a compound based on the modification of erythropoietin, a hormone naturally secreted by the kidneys, whose function is to stimulate the production of red blood cells in the marrow. This means that the more red blood cells there are, the more oxygen they can carry,” he explained. Laura Morelli, a Konizet researcher in the Amyloidosis and Neurodegeneration Laboratory at the LeLore Institute. The problem with overdoing this process is that it creates any kind of changes related to blood clotting or blood physiology. “The positive part is that by carrying oxygen, we are in the presence of molecules that can improve general blood flow and blood flow to the head in a specific way.”, continues with the explanation.

Under this basis, with more blood flow, all brain and cognitive processes improve. “Although not specific to Alzheimer’s disease, it exerts a universal benefit that can contribute in any way to improving the health of patients facing this disease. This drug-modifying antioxidant deficiency is closely linked to the cognitive impairment caused by the pathology.Morelli adds.

As an immediate background, between 2017 and 2020, Phase II trials conducted with this molecule showed adequate safety and efficacy results, as well as a tendency to reduce parameters of cognitive decline and the rate of disease progression in mild and moderate cases. At that time, nasal administration of neuroEPO caused no side effects to volunteers and improved global electroencephalogram values ​​in 72 percent of cases.

Under this precedent, Cuba’s Center for State Control of Medicines, Medical Equipment and Devices (Secmed) conditionally approved the drug in March 2022. The lab will conduct Phase III clinical trials — which are now being reported — with the aim of confirming its effectiveness.

A sovereign island

The Cuban breakthrough, if acted upon, could represent a turning point in approaches to Alzheimer’s treatment. A disease classified as the most common form of dementia, it limits the abilities of those who have it and from here, its course can be changed and, therefore, people’s quality of life can be improved. In Cuba, an estimated 160,000 people have it, and this number is likely to increase over the next decade.

“It is clear that the therapeutic window for progress in the treatment of the disease is not linked to very early and advanced stages. In that respect, the Cuban team is betting on patients where there is still room for improvement,” warns Morelli.

Decades of Western embargo has paradoxically (in some areas) had a beneficial effect. One of them is science and health: except for Oceania, Cuban vaccines are available on all continents. For example, the coronavirus. In record time, and with much less financial resources than large laboratories, the island produced its own vaccines (Soberana 02, Soberana Plus and Abdala) for its entire population and exported them to countries in need. Syria, Iran, St. Vincent and the Grenadines, Vietnam, Venezuela and Mexico.

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