Havana, Feb 26 (RHC) This Monday, February 27, the Phase III Clinical Trial promoted by the Center for Molecular Immunology (CIM) will begin in Cuba to evaluate the efficacy and safety of the neuroprotective drug NeuralCIM (commercial name of the molecule NeuroEPO) in patients with mild or moderate Alzheimer's disease.
Leslie Pérez, clinical promoter of the NeuralCIM® trials, told Cubadebate that two clinical studies with NeuralCIM® will begin, one in Havana and the other in the rest of the country.
In the Cuban capital, the research will be conducted under the title "Evaluation of the efficacy and safety of the administration of NeuralCIM®/NeuralCIM®-Donepezil vs. Donepezil in patients with mild-moderate Alzheimer's disease".
The research will study a sample of 413 people and the patients will be diagnosed not only from a clinical point of view but also from a molecular point of view.
During 18 months approximately, the study will cover 10 hospitals in the capital, including one in primary health care: the Cristóbal Labra polyclinic, in the municipality of La Lisa, Cubadebate reports.
The second study, to be carried out in the rest of the country will include 1,456 patients, and will be focused on the "Evaluation of the effectiveness and safety of the nasal administration of NeuralCIM in patients with mild-moderate Alzheimer's disease phenotype with the amnesic variant".
In this case, the diagnosis will be made from the clinical point of view, since not all the necessary technological equipment is available. For the trial, one hospital in each province was involved, except in the province of Granma, where the Manzanillo and Bayamo hospitals are part of the trial, and in Santiago de Cuba, where the Saturnino Lora and Juan Bruno Zayas hospitals will participate, said the specialized source consulted.
He added that the Phase III clinical trial in the provinces has already started the inclusion in some sites and had its kick-off workshop on January 20. As of February 24, 13 patients had already been included in Santiago de Cuba, Ciego de Avila, and Villa Clara.
The estimated time for this trial in the rest of the country is 24 months, each one of them with midterm analyses to evaluate the fulfillment of the proposed hypotheses.
In March 2022 the drug obtained conditional sanitary registration by the regulatory agency (Cecmed) for mild or moderate Alzheimer's disease. (Source: Cubadebate).
