Cuba has quietly been developing their own Alzheimer's treatment. It's administered nasally. And it's just entered clinical trials.
The United States imposed a blockade against Cuba in 1961, and currently there isn’t much collaboration — or even, much communication — about medical science and research between the U.S. and this island nation. Meanwhile, Cuba has built a robust healthcare system on their own. Most recently, they even developed their own efficacious coronavirus vaccines. Their recent efforts also led them to research the potential of neuroprotective drugs for Alzheimer’s and Parkinson’s disease. Cuban researchers are also on the verge of a Phase 3 clinical trial for a new intranasal Alzheimer’s treatment called NeuralCIM.
Now, clinics in the island nation’s capital are recruiting people with mild to moderate Alzheimer’s to test the effectiveness of their new neuroprotective drug. NeuralCIM mimics the effects of a signaling molecule, erythropoietin, that is important for red blood cells.
In the last two decades, scientists discovered that erythropoietin also plays an important role in the brain providing protection against cell death and facilitating the birth and development of new brain cells — and NeuralCIM is designed to exert these very same effects. This drug is also being tested for Parkinson’s disease in Cuba.
Dr. Leslie Pérez Ruiz from the Center for Molecular Immunology in Cuba is one of the primary investigators in the clinical trial. In an interview with Radio Habana Cuba, she explained that the trial will involve 413 people with mild to moderate Alzheimer’s in Havana.
If successful they would recruit an additional 1,456 for a fourth phase. Once diagnosis is confirmed, people will be randomly assigned to one of three groups: One group will receive NeuralCIM, another will receive the cholinesterase inhibitor donepezil and the third group will receive both.
Though studies show that donepezil may be one of the most effective cholinesterase inhibitors on the market and making this comparison will be important, it should be noted that the clinical trial planned in Cuba does not have a placebo control arm. The drug may also lead to unwanted side effects — in an older population levels of natural erythropoietin which are associated with higher rates of mortality and cardiovascular disease.
In addition, protein-based drugs like erythropoietin tend not to be shelf stable over extended periods of time, and stable storage of these medications can be costly.
Being Patient contacted researchers involved in the clinical trial but they did not respond to requests for comment.