title: Developing drugs for cognitive impairment in schizophrenia.
abstract: There are strong data suggesting that improvement in the cognitive impairment associated with schizophrenia will contribute to enhanced functional outcomes for patients with this illness. Measurement and Treatment Research to Improve Cognition in Schizophrenia was established to provide a pathway for developing and registering potential cognitive-enhancing agents for this condition by addressing issues related to the content of the cognitive assessment battery and the clinical design features to be used in registration studies. This article examines key challenges related to the actual clinical development of cognitive-enhancing agents. These challenges include improving the probability of technical success and attrition rates of candidate molecules, establishing better animal models of human cognition, and developing biomarkers to decrease development costs and increase the speed of the clinical discovery process. Biomarkers are important for molecular target validation, dose selection, surrogate end points, and population segmentation. Examples of approaches for the development of agents for cognitive impairment associated with schizophrenia are discussed. It is concluded that close collaboration among academia, the National Institutes of Health, regulatory bodies, and industry will be important to advance the goal of developing drugs for this important condition.
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. a.breier@lilly.com
authors.forename: Alan
authors.initials: A
authors.lastname: Breier
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology*; D004195:Disease Models, Animal; D017277:Drug Approval; D016527:Drug Costs; D004345:Drug Industry; D004358:Drug Therapy / Q000639:trends*; D023381:Endpoint Determination; D006801:Humans; D012559:Schizophrenia / Q000150:complications*
chemical_list: D015415:Biomarkers