Cuba is in phase III of clinical trials to evaluate the efficacy and safety of the neuroprotective NeuralCIM in patients with Alzheimer’s, the territorial coordinator of the study, Dr. Iralis Benítez, told Prensa Latina.
The tests are performed by the Center for Molecular Immunology. It is specified that on February 27, 2023, two trials of the drug began in parallel.
A study will be carried out in Havana, involving more than 400 people, entitled “Evaluation of the effectiveness and safety of the use of NeuralCIM®/NeuralCIM®-Donepezil vs. Donepezil in patients with mild to moderate Alzheimer’s disease”.
Another trial, in which more than 1,400 patients will participate, will be carried out in the rest of the country, dedicated to the “Evaluation of the efficacy and safety of nasal administration of NeuralCIM in patients with mild to moderate amnestic variant Alzheimer’s disease phenotype” .
This phase of the trial is expected to last 24 months with an interim analysis to assess compliance with the proposed hypotheses.
Prensa Latina recalled that in March last year the drug received conditional medical registration from the Cuban regulatory authority (Cecmed) for the treatment of mild to moderate Alzheimer’s disease.
Earlier, Cubadebate, citing the organizer of the clinical trial Leslie Pérez Ruiz, reported that the study, which will be carried out in Havana, will allow patients to be diagnosed not only from a clinical point of view, but also from a molecular one, as required by the best clinical practices. in the world and various regulatory bodies, for an accurate diagnosis of Alzheimer’s disease. In the rest of the country, this diagnosis will be made from a clinical point of view, since there is not all the necessary technological equipment for molecular tests.
Source: Rossa Primavera
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