期刊
JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE
卷 4, 期 2, 页码 116-124出版社
EDITIONS SERDI
DOI: 10.14283/jpad.2017.13
关键词
Alzheimer's disease; clinical trials; secondary prevention trials; cognitive outcome measures; cognitive composites; patient-reported outcome measures; informant-reported outcome measures; molecular imaging; mild behavioral impairment
资金
- NIA NIH HHS [K24 AG035007, R01 AG046179, R01 AG053798] Funding Source: Medline
At a meeting of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force in December 2016, an international group of investigators from industry, academia, and regulatory agencies reviewed lessons learned from ongoing and planned prevention trials, which will help guide future clinical trials of AD treatments, particularly in the pre-clinical space. The Task Force discussed challenges that need to be addressed across all aspects of clinical trials, calling for innovation in recruitment and retention, infrastructure development, and the selection of outcome measures. While cognitive change provides a marker of disease progression across the disease continuum, there remains a need to identify the optimal assessment tools that provide clinically meaningful endpoints. Patient-and informant-reported assessments of cognition and function may be useful but present additional challenges. Imaging and other biomarkers are also essential to maximize the efficiency of and the information learned from clinical trials.
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