The problem of Alzheimer's does not stop growing and threatens to "undermine social and economic development and overwhelm social and health services" of the entire planet, according to the World Health Organization warns. Currently, there is no effective treatment against the disease and its causes are not even well known. The future is gloomy. The WHO estimates that the number of people suffering from dementia will triple and exceed 150 million in the year 2050 due to the aging of the population. In this hopeless context, the Spanish multinational Grifols announced last Saturday a discovery that would open "a new era in the treatment of Alzheimer's disease". And its value in the Stock Market It increased by 1.210 billion euros.
Scientists have received the announcement with more caution than investors. "In a field where we have failed for many years after failure, any positive news is a rush. But it is not the first time that a news like this occurs, there is a rush of moral-and financial-and then, unfortunately, have come the downs, "says the biochemist Miguel Medina, deputy scientific director of the Network Biomedical Research Center on Neurodegenerative Diseases, in Madrid. "The latest drug against Alzheimer's symptoms, the memantine, was approved in 2003, "recalls Medina.
The stock market value of Grifols increased by 1.210 billion euros after the announcement
On Saturday, October 27, at a scientific conference in Barcelona, Grifols presented "an innovative treatment proposal" that according to his data has achieved "a slowdown of 61% in the progression of the disease" in 120 patients in a moderate stage. The basis of the procedure is very simple. In people with Alzheimer's, a protein called beta amyloid clumps abnormally between brain cells. Most amyloid beta, however, circulates in the blood bound to albumin, the most abundant protein in blood plasma. In his clinical trial, carried out in 41 hospitals in Spain and the US, Grifols has extracted up to three liters of plasma from each patient per week and replaced them with an albumin solution, with the intention of cleaning the amyloid beta in the brain. During the 14 months of treatment, the progression of the disease slowed 61% in those 120 patients compared to another 40 who received a placebo, a simulation of plasma turnover, according to the Spanish multinational.
"It's not a confirmatory trial," he admits. Antonio Páez, medical director of Grifols and principal responsible for the clinical trial. The company is now planning a trial with more patients, as required by the US Food and Drug Administration. If the efficacy and safety of the new experimental treatment are corroborated, other obstacles will have to be considered. "If you have to treat hundreds of thousands of patients there will be a problem with the plasma," warns Páez.
Experts remember that failures in the final stages of experimental treatment trials are counted by the dozens. The American pharmacist Lilly, the British AstraZeneca and the also American MSD In recent months, different clinical trials have been aborted with drugs targeting beta amyloid protein.
"If you have to treat hundreds of thousands of patients there will be a problem with the plasma", warns the medical director of Grifols
"The results [de Grifols] They are very encouraging. We can not say that this treatment will reach the clinic, but it is certainly an investigation that deserves to be continued, "he says. Michael Weiner, Alzheimer's expert at the University of California at San Francisco (USA). The professor, like all independent specialists consulted by this newspaper, regrets the lack of detailed information about the clinical trial. Grifols, for the moment, has only disclosed a brief press release which, for example, does not specify the adverse effects detected. "Plasmatic exchange produces dizziness and hypotension in much less than 1% of patients," says Páez.
The neurologist Lon Schneider, director of the Alzheimer's Research Center at the University of Southern California, believes the results are "potentially compelling," but also criticizes the lack of detailed data on patients' age, their initial cognitive status and other factors that could have contributed to the observed response.
"The most important thing is that this study should be repeated. As has happened with all studies conducted in the last 20 years, there are weaknesses. We are facing a disease that we do not know the causes of, "explains Óscar López, director of the Alzheimer's Research Center at the University of Pittsburgh and co-author of the research. Lopez, however, is optimistic. "There is a high probability that the treatment will reach the public. It should be noted that there are plasma replacement units in practically all the major medical centers of the world, "he emphasizes. These blood purification systems they have been used for decades against autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus.
"There is a high likelihood that the treatment will reach the public," says the director of the Alzheimer's Research Center at the University of Pittsburgh.
Grifols admits that his experimental treatment has worked only in patients with moderate Alzheimer's disease, a phase of the disease characterized by forgetting names of people and by relocation in the home. In another 120 patients in the mild phase, a more initial stage, no improvement was seen during the 15 months. The progression of dementia was calculated with two classical scales, one to measure the ease of performing activities of daily living, such as adding or cooking, and another to determine cognitive capacity, with memory and verbal ability tests. "We can speculate that the scales were not sensitive enough to detect changes in the mild cases", hypothesizes López.
The biochemist Jesús Ávila, scientific director of the Neurological Disease Research Center Foundation, in Madrid, is also optimistic, but cautious. "They are promising results, although preliminary. But this is good news and it is in human patients. In mice we cure Alzheimer's every day, "he says. "The devil is in the details. It happens as with children in schools: a note of progressing properly does not mean that they then pass the course. "
Grifols, headquartered in Barcelona, began its research on Alzheimer's in 2004. Its medical director says that the idea of the clinical trial with plasma exchange was the president himself, Víctor Grifols. Antonio Páez states that the company does not consider registering the procedure for the time being. "Not only do we not worry that our competitors can take advantage of the treatment, but we are willing," he says.