Clinical trial with NeuralCIM® (NeuroEPO) for mild or moderate Alzheimer's begins in Cuba this coming Monday (+ Video)

With the development this Friday of the Phase III Clinical Trial Initiation Workshop promoted by the Molecular Immunology Center (CIM), for the evaluation of the efficacy and safety of the neuroprotective drug NeuralCIM (trade name of the NeuroEPO molecule) in patients with mild Alzheimer's or moderate, everything is ready to start this coming Monday…

According to specialists from the promoter center, the CIM, two clinical studies with NeuralCIM® will begin.

An investigation will be carried out in Havana under the title of

"Evaluation of the efficacy and safety of the administration of NeuralCIM®/NeuralCIM®-Donepezil vs.
Donepezil in patients with mild-moderate Alzheimer's disease”

;

and the other, to be carried out in the rest of the country, focuses on the

"Evaluation of the effectiveness and safety of the nasal administration of NeuralCIM in patients with mild-moderate amnestic variant Alzheimer's disease phenotype."

The first of the studies, in the capital, will reach a sample of 413 people, while the research in the rest of the national territory includes 1,456 patients.

Leslie Pérez Ruiz, clinical promoter of the trials with NeuralCIM® recalled that in March of last year the drug obtained conditional health registration by the regulatory agency (Cecmed) for mild or moderate Alzheimer's disease.

“The research that we are going to carry out throughout the country is very complex,” stressed the Doctor of Science and CIM specialist, who works in the area of clinical trials and neurodegenerative diseases.

He said that

in the arm of the study to be developed in Havana, the patients will be diagnosed not only from a clinical point of view, but also from a molecular one,

as required by good clinical practices in the world and by the different regulatory agencies, for the Accurate diagnosis of Alzheimer's disease.

In the rest of the country, this diagnosis will be made from a clinical point of view, since all the necessary technological equipment is not available.

He explained that the resonances, one of the tests required by the investigation, will be carried out at the Institute of Neurology and Neurosurgery, the Hermanos Ameijeiras hospital and at the Neuroscience Center of Cuba.

The patients will also be studied by SPECT, a complex technique that allows obtaining images of the functioning of different brain regions, among other tests, she added.

The study will cover 10 hospital centers in the capital, including one in primary health care: the Cristóbal Labra polyclinic, in the La Lisa municipality.

Leslie Pérez Ruiz, clinical promoter of trials with NeuralCIM®.

Photo: Cubadebate.

Pérez Ruiz highlighted the accompaniment of the National Clinical Trials Coordinating Center (Cencec) in monitoring good clinical practices in the different research sites.

“In the rest of the country we have a hospital for each province involved in the trial, except in the province of Granma where the Manzanillo and Bayamo hospitals are part, and in Santiago de Cuba where Saturnino Lora and Juan Bruno Zayas will participate. ”, he detailed.

He said that the phase III clinical trial in the provinces has already begun inclusion in some sites and had its initiation workshop on January 20.

As of yesterday, it already has 13 patients included in Santiago de Cuba, Ciego de Ávila and Villa Clara.

As of this coming Monday, caregivers will be able to call the contact numbers listed below, after assessment by the specialist in their Health Area, who will issue a referral to the corresponding secondary care center according to their location. of residence.

The person in charge of the care unit will give the caregiver a turn to take the patient and he or she will be evaluated with a view to their possible inclusion in the trial.

For the rest of the national territory, the procedure for recruiting potential participants to be included in the trial is the same as described above for Havana.

Regarding the fundamental characteristics of the research, the specialist said that the study in Havana will last 18 months, and in the rest of the country it will last 24 months, each with intermediate analyzes to assess compliance with the hypotheses. proposals.

On this Friday, the Workshop for the Initiation of the Phase III Clinical Trial promoted by the CIM was held, for the evaluation of the efficacy and safety of NeuralCIM® in patients with mild or moderate Alzheimer's.

The study will be carried out in Havana and will include 413 patients.

pic.twitter.com/arcGXkRvMS

— Center for Molecular Immunology (CIM) (@cim_cuba) February 24, 2023

NeuralCIM neuroprotective drug (trade name of the NeuroEPO molecule).

Photo: CIM.

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Daily News

Clinical trial with NeuralCIM® (NeuroEPO) for mild or moderate Alzheimer's begins in Cuba this coming Monday (+ Video)

In video: What you should know about the ongoing research with NeuralCIM (NeuroEPO) for Alzheimer's, stroke and ataxia

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