Holguín prepares to start NeuroEpo clinical trial

The inclusion of patients in the NeuroEpo clinical trial (CT) in mild and moderate Alzheimer's will begin in Holguín next September, after a period of organization and evaluation in the territory, where the study will be assumed by the Provincial Group of CT and will include a multidisciplinary team of neurologists, psychiatrists, neuropsychologists, among other specialties.

In the research, whose objective is to determine the effectiveness and safety of NeuroEPO in patients diagnosed with a mild/moderate Alzheimer's disease phenotype, amnesic variant, it is planned to assess between 90 and 100 patients per month, who will be referred by their family doctor or by personal request to this clinical evaluation.

Dr. Zaimar Rodríguez Feria, head of the Provincial EC Group, said that the consultations to determine the insertion of the patients will open at the Lucía Íñiguez Landín surgical- clinical hospital and at the Mental Hygiene Center, located at Coliseo Street No. 213, between Pepe Torres and Carretera Central.

The screening or screening test (diagnostics) will be performed by a multidisciplinary team headed by Dr. Pedro Labrada Aguilera and the doctors Delvis Cabrera Rodríguez, Ana Karenia Gutiérrez, Kirenia Polanco and María Victoria González Jover.

She said that during the treatment, the patients will receive 0.5 mg (0.5 ml) of NeuroEpo three times a week (Monday, Wednesday and Friday) intranasally for 104 weeks and follow-up in consultation throughout that period.

The specialist highlighted that through this study, promoted by the Center for Molecular Immunology and coordinated by the National Center for Clinical Trials (CENCEC), the safety of the product will be evaluated by reporting adverse effects by the patient and/or reliable informant, in addition to the clinical and laboratory evaluation of the individual in the follow-up consultations.

She clarified that patients with decompensated underlying diseases, cognitive impairment due to other non-Alzheimer's causes and patients treated with approved medications for this disease will not have inclusion criteria.
During the CT, two interim analyzes will be performed, one at week 52 and another at 78. If the probability of success is much higher (> 0.9), the study is stopped due to success.

This is a phase IV, multicenter, national, open, adaptive and non-randomized CT, which will include 1,456 patients aged 19 years or older and with a clinical diagnosis of Alzheimer's disease phenotype, amnesic variant