BIOMIT Center for Molecular Immunology - CIM

New clinical trials with NeuralCIM® in Alzheimer's, Stroke and Ataxia

Tuesday, February 28, 2023

Author: Sonia Ponce de León Villafuerte

Source: CIM

External Source: NP

images/Content/noticias/67d6c2a6-2922-450a-8383-41f3e6770d2c.jpg Mild or moderate Alzheimer's clinical trial <br /> <br />The Center for Molecular Immunology (CIM) will begin the two clinical studies with NeuralCIM®. 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 in the rest of the country, with the title "Evaluation of the effectiveness and safety of the nasal administration of NeuralCIM in patients with the phenotype of Alzheimer's disease mild-moderate amnestic variant." <br /> <br />The study to be developed in the capital (10 hospitals), will have its start workshop on February 24. As of that date, caregivers may call the contact numbers listed below, after assessment by the specialist in their Health Area, who will issue a remittance to the corresponding secondary care center according to their place of residence. home. 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. <br /> <br />The study to be carried out in the rest of the country (16 hospitals), already had its initiation workshop on January 20 and inclusion began in some sites. The procedure for recruiting potential participants to be included in the trial is the same as described above for Havana. <br /> <br />ICTUS Clinical trial <br /> <br />On February 16, the initiation workshop of the PHASE I-II Clinical Trial Evaluation of the Safety and effect of NeuroEPO in patients with Acute Cerebral Infarction (SErONICA) was held. <br /> <br />It will take place in four institutions in the capital: Carlos J. Finlay Hospital (main site), National Institute of Neurology and Neurosurgery (INN), Enrique Cabrera Hospital and Comandante Manuel Fajardo Hospital. The principal investigator of the study is Dr. Luisa Paz Sendin, a second degree specialist in Neurology, belonging to the Finlay Hospital. <br /> <br />In order to be assessed for inclusion in the study, you must go to one of the hospitals mentioned above, in less than 48 hours after the onset of symptoms compatible with a possible ischemic cerebrovascular disease. These symptoms are: sudden loss of vision in one or both eyes, sudden difficulty walking, loss of balance or coordination, sudden onset severe headache with no known cause, loss of strength in one half of the body (face, arm and leg on the same side), difficulty speaking and understanding language, loss of sensation or tingling in the middle of the body and sudden deviation of the corner of the mouth. <br /> <br />ATAXIA Clinical trial <br /> <br />On March 9, the initiation workshop of the phase III clinical trial, placebo-controlled, randomized and double-blind, should be held to evaluate the efficacy and safety of the nasal administration of NeuroEPO in adult patients with spinocerebellar ataxias (NESCA study), after after having obtained its approval by the Cuban regulatory agency (CECMED). <br /> <br />This investigation will be monitored by CENCEC. It will be developed in the following institutions in the province of Holguín (province with the highest prevalence of this disease): CIRAH (Center for Research and Rehabilitation of Hereditary Ataxias) which will serve as the main site and is attached to the Lucía Iñiguez Clinical Surgical Hospital Landín” from the same province; as well as at the "Arnaldo Milían Castro" Clinical Surgical Hospital in Villa Clara and the National Institute of Neurology and Neurosurgery (INN) in the Cuban capital. The principal investigator of the study is Dr. Cs. Luis Velázquez Pérez, second degree specialist in Neurophysiology and Neurology, founder of CIRAH and currently president of the Cuban Academy of Sciences. <br />To be evaluated for inclusion in the study, one must go to one of the clinical sites mentioned above and in consultations that will be set up and have clinical, family and/or molecular elements of the variants of spinocerebellar ataxia that prevail in our country. This will allow researchers to include patients who meet the inclusion criteria and of course do not have exclusion criteria. This degenerative disease of the central nervous system has a hereditary and familial component and is characterized by disorders of gait, language, movement coordination, among other symptoms and signs. It is expected that, with NeuroEPO, a slowing down of the progression of this disease will be achieved, which today does not have drugs for its cure and/or slowing down its progression. <br /> <br />*After the initiation workshop, the contact details for inquiries will be published on the institutional channels of the CIM or they can be requested through the institutional mail.

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