title: Improving Alzheimer's disease phase II clinical trials.
abstract: Over the past 30 years, many drugs have been studied as possible treatments for Alzheimer's disease, but only four have demonstrated sufficient efficacy to be approved as treatments, of which three are in the same class. This lack of success has raised questions both in the pharmaceutical industry and academia about the future of Alzheimer's disease therapy. The high cost and low success rate of drug development across many disease areas can be attributed, in large part, to late-stage clinical failures (Schachter and Ramoni, Nat Rev Drug Discov 2007;6:107-8). Thus, identifying in phase II, or preferably phase I, drugs that are likely to fail would have a dramatic impact on the costs associated with developing new drugs. With this in mind, the Alzheimer's Association convened a Research Roundtable on June 23 and 24, 2011, in Washington, DC, bringing together scientists from academia, industry, and government regulatory agencies to discuss strategies for improving the probability of phase II trial results predicting success when considering the go/no-go decision-making process leading to the initiation of phase III.
authors.affiliation: Division of Neuroscience Drug Discovery and Development, University Health Network, Toronto, ON, Canada.
authors.forename: Barry D
authors.initials: BD
authors.lastname: Greenberg
authors.forename: Maria C
authors.initials: MC
authors.lastname: Carrillo
authors.forename: J Michael
authors.initials: JM
authors.lastname: Ryan
authors.forename: Michael
authors.initials: M
authors.lastname: Gold
authors.forename: Kim
authors.initials: K
authors.lastname: Gallagher
authors.forename: Michael
authors.initials: M
authors.lastname: Grundman
authors.forename: Robert M
authors.initials: RM
authors.lastname: Berman
authors.forename: Timothy
authors.initials: T
authors.lastname: Ashwood
authors.forename: Eric R
authors.initials: ER
authors.lastname: Siemers
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D017322:Clinical Trials, Phase II as Topic; D003362:Cost-Benefit Analysis; D006801:Humans; D018696:Neuroprotective Agents / Q000191:economics* / Q000494:pharmacology*
chemical_list: D018696:Neuroprotective Agents