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by
Ronald Black |
Total Records (
2 ) for
Ronald Black |
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Ronald Black
,
Barry Greenberg
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J. Michael Ryan
,
Holly Posner
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Jeffrey Seeburger
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Joan Amatniek
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Malca Resnick
,
Richard Mohs
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David S. Miller
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Daniel Saumier
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Maria C. Carrillo
and
Yaakov Stern
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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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Rachelle S. Doody
,
Patricia E. Cole
,
David S. Miller
,
Eric Siemers
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Ronald Black
,
Howard Feldman
,
Rachel Schindler
,
Stephen Graham
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Theresa Heath
,
Ara S. Khachaturian
,
Rebecca Evans
and
Maria C. Carrillo
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The number of clinical trials for Alzheimer‘s disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural and ethical context of global clinical trials, potential benefits for those involved, and practical approaches to obstacles generated by these global trials were discussed at a meeting of the Alzheimer‘s Association Research Roundtable. Regulatory issues, including regional differences in study registration procedures, rules for collecting and reporting serious adverse events, requirements for national identity of study populations, and regulatory audits were also discussed by individuals who are knowledgeable about global clinical trials for Alzheimer‘s disease. |
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