10 research outputs found
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Scales as outcome measures for Alzheimer's disease
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
Bone graft substitutes in anterior cervical discectomy and fusion
Anterior cervical discectomy with fusion is a common surgical procedure for patients suffering pain and/or neurological deficits and unresponsive to conservative management. For decades, autologous bone grafted from the iliac crest has been used as a substrate for cervical arthrodesis. However patient dissatisfaction with donor site morbidity has led to the search for alternative techniques. We present a literature review examining the progress of available grafting options as assessed in human clinical trials, considering allograft-based, synthetic, factor- and cell-based technologies