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Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes

Translational Neurodegeneration 2014年第1期3卷 89-97页

作者： Justin B Miller Sarah J Banks Gabriel C Léger Jeffrey L Cummings Cleveland Clinic Lou Ruvo Center for Brain Health888 W.Bonneville AveLas VegasNevada 89106USA

Progress has been made in understanding the genetics and molecular biology of frontotemporal dementia(FTD).Targets for intervention have been identified,therapies are being developed,and clinical trials are advancing.A major challenge for FTD research is that multiple underlying pathologies can be associated with heterogeneous *** neuropsychological profiles associated with FTD spectrum disorders often include executive dysfunction,language impairments and behavioral *** variant FTD is characterized by an initial presentation of changes in personality,behavior and/or emotion,which are often difficult to objectively capture using traditional neuropsychological *** two principal language variants of FTD are Progressive Nonfluent Aphasia(PNFA)with predominant agrammatic/non-fluent impairments and Semantic Dementia(SD)with semantic impairments and visual *** of appropriate endpoints for clinical trials is critical to ensure that the measures are adequately sensitive to detect change,yet specific enough to isolate signal from noise,and acceptable to regulatory *** the anticipated potential for small effect sizes,measures must be able to identify small incremental changes over *** is also imperative that the measures provide adequate coverage of the constructs or behaviors of *** outcome measures should be suitable for repeat administration,yet relatively robust to practice effects to ensure that observed changes reflect true signal variance and not residual effects due to repeated measurement or poor *** facilitate widespread adoption as an endpoint,measures should be readily *** provide several examples of potential global,composite,and individual cognitive measures,as well as behavioral measures promising for FTD *** and application of appropriate trial outcomes is critically important to success in advancing new treatments for FTD patients.

关键词： Frontotemporal dementia Primary endpoints secondary endpoints Randomized controlled trial Methods

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