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The Cleveland Clinic's fourth annual Alzheimer's Drug Development pipeline presents a new round of clinical trials to give clinicians a comprehensive overview of ongoing research in the United States.
The researchers, led by Dr. Jeffrey Cummings, director emeritus of the Cleveland Lou Ruvo Clinic for Brain Health, have identified all the pharmacological trials on Alzheimer's disease under development. Clinicaltrials.gov. They found 132 agents currently in 156 clinical trials – including 28 in 42 phase 3 trials; 74 in 83 phase 2 trials; and 30 in 31 phase 1 trials.
Currently, the Alzheimer's disease pipeline has 19 agents participating in cognitive enhancement trials, 14 dealing with neuropsychiatric and behavioral symptoms and 96 agents participating in disease modification trials, 38 of which focus on on amyloid as the main target or as one of several effects.
Of the amyloid targeting agents, 18 are small molecules and are monoclonal antibodies or biological therapies. 7 small molecules and 10 biological products whose tau protein is the main target or combination are also under development.
The team also discovered new features in clinical trials, including new biomarkers and results, prior population enrollment, and innovative trial designs.
AD has very few treatment options available, as most drug development programs are challenging and have failed, which is evident in the fact that no new drugs have been approved to treat the drug. disease since 2003.
However, Aaron Ritter, MD, director of clinical trials at the Lou Ruvo Center, explained in an interview with MD Magazinea how drug development pathways identify the evolution of drug development and lead to optimized development practices.
"I think what really concerns us is that the targets for the drugs are different," Ritter said. "At this point, we know that some proteins are badociated with Alzheimer's disease, but we still do not know what actually makes the disease progress and why some people get it and others do not. . "
Ritter explained that the main difference between the first iteration of the pipeline and the current version is that testing has become more advanced, diverse and sophisticated.
As the population ages, investigators should continue to lobby for a better understanding of AD.
"As the population ages, the fastest growing population will be the population over 90 in the next 20 to 30 years," Ritter said. "The question is, are we 100 feet or 10 feet away from solving the problem?"
However, while research in this area continues to grow, Ritter said that it was absolutely necessary that people with and those at risk of developing the disease participate in clinical trials, estimating that 50,000 people in the United States Are needed to test all drugs. therapies currently underway.
At present, the US Food and Drug Administration (FDA) has guidelines for clinical trials on dementia and dementia badociated with AD, including the use of a drug. only primary endpoint in prodromal DA trials, the role of biomarkers in the staging of preclinical and prodromal DA and the use of Bayesian statistics. and models of adaptive clinical trials.
The National Institute of Aging has also published a new research framework based on the biomarkers of amyloid, tau protein and neurodegeneration to allow for more accurate clbadification of AD stages, particularly stages of prédementia.
Ritter said that one of the problems preventing research is that there is not much openness to the work of the major research institutions.
"One of the major problems of any type of research is that it is often divided into different institutions, that's the way research has developed in this country," he said. "The idea of the pipeline is simply to give a general overview of what everyone is doing and to hopefully encourage some collaborations."
The study, "Drug Development Pipeline for Alzheimer's Disease: 2019, "Was published online in Alzheimer's and Dementia: Translational Research and Clinical Interventions.
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