Billions of dollars have been spent on clinical trials for Alzheimer's drugs that target amyloid plaques, tangles of proteins that clog stamp brain cells in people with the memory-stealing disease. So far, all have failed, leading some frustrated researchers say it is time to move on to other drug targets. Others say that the drugs are not tested enough because they were administered too late, after brain damage is irreversible. Yesterday, the National Institutes of Health (NIH) announced that it gave $ 33 million to a study that researchers hope or reliving the amyloid hypothesis, or to bed
The new cost-trial is estimated to be at least $ 100 million overall, with most of the remaining funds provided by partners in the pharmaceutical industry will be part of the Prevention Initiative Alzheimer's disease, a large consortium of researchers trying to identify biomarkers and treatments that can slow or stop the disease. The lead researchers Eric Reiman and Pierre Tariot Institute Banner Alzheimer Phoenix plan to provide a drug that is yet to be identified anti-amyloid, or a placebo, 650 people who carry two copies of APOE4 general a double whammy gene that confers increased 10 risk factor for developing late Alzheimer's disease in life. All participants will be aged between 60 and 75 and in good health, including recognized Alzheimer's symptoms. About a third probably will not be much amyloid in their brains again, allowing researchers to track whether the drug affects its accumulation, Reiman said.
The Banner trial "is a very reasonable approach" to determine whether anti-beta amyloid drugs can effectively prevent Alzheimer's disease, said Gary Landreth, a neurologist who studies the disease at Case Western Reserve University in Cleveland, Ohio. He notes, however, that it is quite unusual that the drug be used has not yet been identified, given the size of the grant. since no anti-amyloid / drugs Alzheimer yet shown any clinical efficacy, "I think it really reflects the state of despair felt in the scientific community and the public that we have no effective therapeutic in the face of an epidemic over AD, "he said." They take a gamble. "
The APOE4 test is based on another test of an anti drug -amyloid in 300 members of a Colombian family who carry a mutation of the gene that puts them at high risk of developing a form of early onset Alzheimer's disease. Rather than wait for the results of this study, Reiman said he and his colleagues decided to conduct two trials simultaneously to ensure that the positive results of the Colombian study can be rapidly tested in a representative population-drugs working for those early-onset Alzheimer's may not necessarily help people with late-onset Alzheimer's, he said.
Maria Carrillo, vice president of medical and scientific relations for the Alzheimer's Association, an advocacy group, applauded NIH to give the green light Trial: Targeting APOE4 people will "increase the possibility that the trial participants become symptomatic during the period of the study so that the scientists can assess whether the intervention of the drug is having an impact on delaying or preventing Alzheimer's disease symptoms without having to wait 10 or 15 years or more, "she said.
the US government has placed a high priority on the fight against Alzheimer's disease, which is expected to hit 10 million Americans in 2050, according to the US Department of Health and Human Services (HHS). The Act on the draft 2011 National Alzheimer's, for example, demanded that HHS develop a national plan to prevent or effectively treat Alzheimer's disease in 2025. The new APOE study will use to share the lion of the $ 45 million that Francis Collins, NIH director, has set aside for Alzheimer's research during fiscal 2013. (total of $ 45 million includes a contribution of $ 5 million of the Institute National on aging [NIA]). According to Neil Buckholtz, director of the NIA Division of Neuroscience, the investment reflects a move towards trying to prevent the disease before it ravages the brain, rather than reverse its effects, and a commitment to test the hypothesis that amyloid correctly . "We believe that this has not been sufficiently tested," he said. He acknowledged, however, that putting so many dollars of research into one basket is a strategy "high risk"
NIH also announced funding for five additional grants to Alzheimer's research, with a sixth reward waiting :.
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$ 1,5 M test test three new anti-amyloid treatments of gantenerumab-beta drugs, solanezumab, and a third drug in indefinite volunteers with an inherited form of early onset Alzheimer's disease. Directed by Randall Bateman from the University of Washington St. Louis, international trial has the potential to earn $ 6 million in funding over 4 years.
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Phase A $ 2.4 million, 12 weeks 1 test test safety and tolerability of allopregnanolone steroids for the treatment of mild cognitive impairment and Alzheimer's disease, led by Roberta Brinton and Lon Schneider of the University of Southern California in Los Angeles. Animal studies have shown that the drug can lower amyloid levels, restore cognitive function, and stimulate the production of new neurons.
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A $ 1.7 million drug discovery effort to identify genetic and molecular risk factors and new therapeutic target for cognitive decline and Alzheimer's disease, on the religious study database Order and memory and aging Project Rush. Led by Philip De Jager Brigham and Women's Hospital, Broad Institute and Harvard University, and David Bennett of the Rush University Medical Center in Chicago, the study will focus on drugs that have completed Phase 1 trials , and may be granted $ 7.9 million over 5 years.
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A $ 1.6 million effort to study the complex mechanisms of the disease and to identify existing drugs that might be able to be used for treatment or prevention of Alzheimer's disease, led by Eric Schadt of Mount Sinai School of Medicine in New York. The study has the potential to be granted $ 8.2 million over 5 years.
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A $ 1.6 million study of the role of the immune system and inflammation of the brain in Alzheimer's disease directed by Todd Golde of the University of Florida in Gainesville. The study has the potential to be granted $ 7.7 million over 5 years.
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