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Articles by Michael Grundman
Total Records ( 3 ) for Michael Grundman
  Zaven S. Khachaturian , Deborah Barnes , Richard Einstein , Sterling Johnson , Virginia Lee , Allen Roses , Mark A. Sager , William R. Shankle , Peter J. Snyder , Ronald C. Petersen , Gerard Schellenberg , John Trojanowski , Paul Aisen , Marilyn S. Albert , John C.S. Breitner , Neil Buckholtz , Maria Carrillo , Steven Ferris , Barry D. Greenberg , Michael Grundman , Ara S. Khachaturian , Lewis H. Kuller , Oscar L. Lopez , Paul Maruff , Richard C. Mohs , Marcelle Morrison- Bogorad , Creighton Phelps , Eric Reiman , Marwan Sabbagh , Mary Sano , Lon S. Schneider , Eric Siemers , Pierre Tariot , Jacques Touchon , Bruno Vellas and Lisa J. Bain
  Among the major impediments to the design of clinical trials for the prevention of Alzheimer's disease (AD), the most critical is the lack of validated biomarkers, assessment tools, and algorithms that would facilitate identification of asymptomatic individuals with elevated risk who might be recruited as study volunteers. Thus, the Leon Thal Symposium 2009 (LTS'09), on October 27–28, 2009 in Las Vegas, Nevada, was convened to explore strategies to surmount the barriers in designing a multisite, comparative study to evaluate and validate various approaches for detecting and selecting asymptomatic people at risk for cognitive disorders/dementia. The deliberations of LTS'09 included presentations and reviews of different approaches (algorithms, biomarkers, or measures) for identifying asymptomatic individuals at elevated risk for AD who would be candidates for longitudinal or prevention studies. The key nested recommendations of LTS'09 included: (1) establishment of a National Database for Longitudinal Studies as a shared research core resource; (2) launch of a large collaborative study that will compare multiple screening approaches and biomarkers to determine the best method for identifying asymptomatic people at risk for AD; (3) initiation of a Global Database that extends the concept of the National Database for Longitudinal Studies for longitudinal studies beyond the United States; and (4) development of an educational campaign that will address public misconceptions about AD and promote healthy brain aging.
  Reisa A. Sperling , Clifford R. Jack , Sandra E. Black , Matthew P. Frosch , Steven M. Greenberg , Bradley T. Hyman , Philip Scheltens , Maria C. Carrillo , William Thies , Martin M. Bednar , Ronald S. Black , H. Robert Brashear , Michael Grundman , Eric R. Siemers , Howard H. Feldman and Rachel J. Schindler
  Amyloid imaging related abnormalities (ARIA) have now been reported in clinical trials with multiple therapeutic avenues to lower amyloid-β burden in Alzheimer‘s disease (AD). In response to concerns raised by the Food and Drug Administration, the Alzheimer‘s Association Research Roundtable convened a working group to review the publicly available trial data, attempts at developing animal models, and the literature on the natural history and pathology of related conditions. The spectrum of ARIA includes signal hyperintensities on fluid attenuation inversion recoverysequences thought to represent ”vasogenic edema“ and/or sulcal effusion (ARIA-E), as well as signal hypointensities on GRE/T2∗ thought to represent hemosiderin deposits (ARIA-H), including microhemorrhage and superficial siderosis. The etiology of ARIA remains unclear but the prevailing data support vascular amyloid as a common pathophysiological mechanism leading to increased vascular permeability. The workgroup proposes recommendations for the detection and monitoring of ARIA in ongoing AD clinical trials, as well as directions for future research.
  Barry D. Greenberg , Maria C. Carrillo , J. Michael Ryan , Michael Gold , Kim Gallagher , Michael Grundman , Robert M. Berman , Timothy Ashwood and Eric R. Siemers
  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.
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