HAVANA, July 7th A phase III clinical trial of the national drug against Alzheimer‘s, NeuralCIM -trade name of NeuroEPO- will soon begin in Cuba, for which classification consultations for the patients who will participate in the study began yesterday in Havana.
Although this preliminary investigation does not mean the full start of the clinical trial, it constitutes an important step to advance in the correct diagnosis of patients and in the identification of the population that will be included, Doctor of Science Kalet León Monzón explained to the press on Wednesday. , First Deputy Director of the Center for Molecular Immunology (CIM).
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Among the places in the capital where shifts can be requested for consultations are the Medical-Surgical Research Center (Cimeq), and the Salvador Allende, Manuel Fajardo, Hermanos Ameijeiras hospitals, as well as the Neurology Institute.
Doctor of Science Leslie Pérez Ruiz, promoter of the CIM’s Alzheimer’s clinical trial, explained that, currently, there is a database of more than 400 patients, of which 371 are from Havana.
She stated that 310 of the caregivers have been located, who can call and are assigned a shift for the consultation, in which it will be identified if the patient has a mild/moderate Alzheimer’s pattern.
According to Dr. Pérez Ruiz, phase III of the study is likely to start next September or October, and it seeks to evaluate the efficacy and safety of this formulation for nasal administration.
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In that sense, he explained that NeuralCIM will be compared with Donepezil, a drug approved since the 1990s by the US Drug Regulatory Agency, meanwhile, for the first time in Cuba, the patient will undergo a molecular diagnosis for Alzheimer’s, not just clinical.
She stated that a phase IV trial will be carried out in the rest of the country, in patients with a mild/moderate disease phenotype (amnesic variant), whose diagnosis will only be clinical.
Dr. Pérez Ruiz also stated that the medication will be applied by the caregiver at home, who will be trained in the Health institutions for the correct administration of the NeuralCIM.