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The latest US-approved Alzheimer's drug – a new package of two existing drugs in a single pill – was given the go-ahead in 2003. In the two decades since then, many failures have failed in the development of a new treatment for the most common treatment. form of dementia. The latest was in March when Biogen and partner Eisai announced the failure of a drug targeting the accumulation of amyloid proteins in the brain, features of the disease.
The constant failure of clinical trials on Alzheimer's disease is one of the major factors that have made the future development of more expensive drugs. At the end of last year, researchers at the Cleveland Lou Ruvo Clinic for Brain Health in Las Vegas estimated that the total cost of developing any new Alzheimer's drug, including chess, was estimated at 5, $ 7 billion, double the average cost of drug development. Their published work (paywall) in Alzheimer's and Dementia Translational Research and Clinical Interventions (a journal created by the nonprofit Alzheimer's Association), estimated that it would take $ 38.4 billion dollars to create a promising pipeline of drugs that can also fight the disease. several different approaches.
Historically, clinical trials of Alzheimer's drugs began late in the progression of the disease in participants. Scientists know that accumulations of amyloid proteins and another type called tau can begin to accumulate in the brain for years, even decades, before a person begins to experience symptoms loss of memory or cognition disorders. However, once the symptoms appear, it is often too late: they irreversibly damage groups of neurons so that the brain can not recover. Medications may slow down some of these participants' symptoms, but they can not repair any of the damage caused by the disease.
Ideally, clinical trials should start earlier, before participants begin to show symptoms. The problem is that it is almost impossible to identify these patients. The brain is a resilient organ. if he discovers that some of the methods used to perform normal tasks, such as memorizing task lists or new knowledge names, are compromised, he can rely on other connections and neural regions to conduct it Oh good. It also has no pain receptor. People who develop the disease have no idea what's wrong. Scientists are working on ways to identify biomarkers – other changes in blood proteins, cognition or even the eye – to try to identify such individuals, but for the moment no one is ready for clinical use.
In addition to the difficulty of finding appropriate participants for Alzheimer's research, clinical trials take years because the disease evolves very slowly. The authors of the article above estimate that it takes more than 13 years for a drug to go through all the clinical trials required to get approval from the US Food and Drug Administration. . Pharmaceutical Research and Manufacturers of America, a group specializing in lobbying pharmaceutical companies, estimates that this process takes on average about a decade (pdf) for other drugs.
Cancer drugs, on the other hand, require far less resources and time than other types of drugs. They have much shorter clinical trials where success is measured by increased survival rates, and often graft on existing treatments to bring incremental improvements.
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