Scales as outcome measures for Alzheimer's disease |
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| Authors: | Ronald Black Barry Greenberg J. Michael Ryan Holly Posner Jeffrey Seeburger Joan Amatniek Malca Resnick Richard Mohs David S. Miller Daniel Saumier Maria C. Carrillo Yaakov Stern |
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| Affiliation: | 1. Wyeth Research, Collegeville, PA, USA;2. Toronto Western Research Institute, Toronto, Ontario, Canada;3. Eisai Medical Research, Inc., New York, NY, USA;4. Merck Research Laboratories, North Wales, PA, USA;5. Ortho-McNeil Neurologics, Inc., Raritan, NJ, USA;6. Forest Laboratories, Inc., New York, NY, USA;7. Eli Lilly & Co., Indianapolis, IN, USA;8. United BioSource Corporation, Wayne, PA, USA;9. Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada;10. BELLUS Health, Inc., Laval, Quebec, Canada;11. Alzheimer''s Association, Chicago, IL, USA;12. Department of Clinical Neuropsychology, Taub Institute, Columbia University, New York, NY, USA;1. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA;2. Evidera, formerly United BioSource Corporation (UBC), Lexington, MA, USA;3. Xcenda, Palm Harbor, FL, USA;4. Merck, Kenilworth, NJ, USA;5. Outcometrix, Tucson, AZ, USA;6. Bracket, Wayne, PA, USA;7. Genentech, South San Francisco, CA, USA;8. Alzheimer''s Disease and Memory Disorders Center, Baylor College of Medicine, Houston, TX, USA;9. University of California, San Diego, School of Medicine, San Diego, CA, USA;10. McGill Centre for Studies in Aging, Montreal, Canada;11. Patient-Centered Outcomes Research Institute (PCORI), Washington, D.C, USA;1. Department of Pediatrics, Section of Pediatric Cardiology, Yale School of Medicine, New Haven, Connecticut;2. Department of Medicine, Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut;3. Heart and Vascular Center, Pediatric Echocardiography Laboratory, Yale New Haven Hospital, New Haven, Connecticut;4. Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut;1. Institute for Physiology und Pathophysiology, University of Heidelberg, Im Neuenheimer Feld 326, 69120 Heidelberg, Germany;2. Division of Neuroscience, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK;1. Department of Neurology, Rhode Island Hospital & Alpert Medical School of Brown University, Providence, RI, USA;2. Eli Lilly & Co, Inc., Indianapolis, IN, USA;3. Takeda Development Center Americas, Inc., Deerfield IL, USA;4. Bracket, Wayne, PA, USA;5. Pfizer, Inc., New York, NY, USA;6. Piramal Pharma Inc., Boston, MA, USA;7. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA;8. Lumos Labs, San Francisco, CA, USA;9. Global R&D Partners, LLC, San Diego, CA, USA;10. Merck & Co., Whitehouse Station, NJ, USA;11. Department of Neurology, Mayo Clinic Arizona, Scottsdale, AZ, USA;12. European Medicines Agency (EMA), London, UK;13. Independent Science Writer, Elverson, PA, USA;14. Alzheimer''s Association, Chicago, IL, USA |
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| Abstract: | The assessment of patient outcomes in clinical trials of new therapeutics for Alzheimer's disease (AD) continues to evolve. In addition to assessing drugs for symptomatic relief, an increasing number of trials are focusing on potential disease-modifying agents. Moreover, participants with AD are being studied earlier in their course of disease. As a result, the limitations of current outcome measures have become more apparent, as has the need for better instruments. In recognition of the need to review and possibly revise current assessment measures, the Alzheimer's Association, in cooperation with industry leaders and academic investigators, convened a Research Roundtable meeting devoted to scales as outcome measures for AD clinical trials. The meeting included a discussion of methodological issues in the use of scales in AD clinical trials, including cross-cultural issues. Specific topics related to the use of cognitive, functional, global, and neuropsychiatric scales were also presented. Speakers also addressed academic and industry initiatives for pooling data from untreated and placebo-treated patients in clinical trials. A number of regulatory topics were also discussed with agency representatives. Panel discussions highlighted areas of controversy, in an effort to gain consensus on various topics. |
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