title: Alzheimer's disease drug development: translational neuroscience strategies.
abstract: Alzheimer's disease (AD) is an urgent public health challenge that is rapidly approaching epidemic proportions. New therapies that defer or prevent the onset, delay the decline, or improve the symptoms are urgently needed. All phase 3 drug development programs for disease-modifying agents have failed thus far. New approaches to drug development are needed. Translational neuroscience focuses on the linkages between basic neuroscience and the development of new diagnostic and therapeutic products that will improve the lives of patients or prevent the occurrence of brain disorders. Translational neuroscience includes new preclinical models that may better predict human efficacy and safety, improved clinical trial designs and outcomes that will accelerate drug development, and the use of biomarkers to more rapidly provide information regarding the effects of drugs on the underlying disease biology. Early translational research is complemented by later stage translational approaches regarding how best to use evidence to impact clinical practice and to assess the influence of new treatments on the public health. Funding of translational research is evolving with an increased emphasis on academic and NIH involvement in drug development. Translational neuroscience provides a framework for advancing development of new therapies for AD patients.
authors.affiliation: Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas, NV, USA. cumminj@ccf.org
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Cummings
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Banks
authors.forename: Ronald K
authors.initials: RK
authors.lastname: Gary
authors.forename: Jefferson W
authors.initials: JW
authors.lastname: Kinney
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Lombardo
authors.forename: Ryan R
authors.initials: RR
authors.lastname: Walsh
authors.forename: Kate
authors.initials: K
authors.lastname: Zhong
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D000818:Animals; D015415:Biomarkers; D006801:Humans; D008959:Models, Neurological; D009488:Neurosciences / Q000379:methods* / Q000639:trends; D012109:Research Support as Topic; D057170:Translational Research, Biomedical / Q000379:methods* / Q000639:trends
chemical_list: D015415:Biomarkers