A goal of many clinical trials for Alzheimer's disease is to develop disease-modifying therapies for the pre-dementia period of the Alzheimer's disease process. However, there are no clinical criteria for characterizing subjects in this range. The construct of amnestic mild cognitive impairment has been extensively investigated and may provide useful clinical criteria for this clinical stage. It is proposed that the clinical criteria for mild cognitive impairment be enriched with imaging and other biomarkers to improve the specificity of the outcome, and these criteria might suffice for pre-dementia clinical trials.
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