There are two trials, one is being made in Havana and the other at nationwide. In the first case, there are three groups of treatments: one by using NeuralCIM of the Center for Molecular Immunology (CIM), the second one, which is the active control, uses Donepezil, a compound approved since the 90’s.
The third group uses NeuralCIM combined with Donepezil, CIM clinical promoter Lesly Pérez told Prensa Latina.
In this phase III we seek to increase all information on the safety data we have from last trial, which made it possible for the Cuban regulatory agency to give us the conditional registration of the product.
Now we are on the way to obtaining the definitive registration, once the safety results obtained are confirmed.
So far, 106 patients have been included in this research, the sample is 413, so we will have to continue checking more people, possibly up to 700.
It is necessary,” said Perez, “for the population to know in which institutions the recruitment process is being carried out.
Of course, citizens must first undergo an evaluation consultation in primary health care, since “all dementias are not Alzheimer’s, and all forgetfulness is not dementia either”.
An in-depth medical check-up is made and if they meet the criteria of the research, they are included in the clinical trial.
The most important thing is that these people will always have the attention of an expert, Perez assured.
Neuropsychological evaluation is vital, as is the role played by neurologists, clinicians, geriatricians, among other specialists.
He regretted the use of lumbar puncture, because it is an invasive method for an adult aged over 65, but it is the biomarker we have in Cuba.
In medicine, lumbar puncture or spinal tap is a procedure commonly performed to obtain samples of cerebrospinal fluid for diagnostic purposes for biochemical analysis.
Once the inclusion criteria have been met, treatment will be conducted at home and overseen by a caregiver who will be previously trained.
It is too easy to undertake, since they are nasal drops applied on Mondays, Wednesdays and Fridays for 78-week time, and it has an evaluation at 52nd weeks, and if the effectiveness of the clinical trial is very high it can be closed for success, otherwise it is concluded for non-effectiveness.
Side effects are minimal and are located in the nasal area, but never as those produced by most of the drugs approved in the world that Cuba does not have access to, hence the importance of research.
The greatest value of our endeavor would be that it would be the first drug created in Cuba to fight off Alzheimer’s disease.
It does not mean that we are going to cure patients, but that we are going to slow down the cognitive deterioration, thus improving their quality of life and reducing the wear and tear of their caregivers.
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