The Horizon 2020/IMI European Prevention of Alzheimer’s Dementia (EPAD) project will undertake large-scale proof-of-concept trials in predementia Alzheimer’s disease (AD). Within EPAD, the monitoring of cognitive trajectories in the preclinical period will constitute a central outcome measure; however, there are currently no clear guidelines as to how this should be achieved as most measures have been developed for the period around dementia diagnosis. The EPAD Scientific Advisory Group for Clinical and Cognitive Outcomes identified appropriate cognitive measures based on a literature search covering both cognitive correlates of preclinical brain changes from imaging studies and cognitive changes observed over time in nondementia population cohorts developing incident dementia. These measures were evaluated according to the following criteria: validity, coherence with biomarker changes, psychometric properties, cross-cultural suitability, availability of alternative forms, and normative data limited practice effects. The resulting consensus statement provides recommendations for both future drug trials and research into preclinical Alzheimer’s disease.
About the Author
Dr. Christopher Randolph is Chief Scientific Officer at MedAvante/Prophase and Clinical Professor of Neurology at Loyola University Medical Center. Dr. Randolph has extensive experience in CNS clinical trials work, as an investigator, consultant and creator and supervisor of rater training programs for a large number of Phase II and Phase III multinational studies in Alzheimer’s disease and other neurodegenerative conditions; schizophrenia; stroke; hepatic encephalopathy; and traumatic brain injury.More Content by Dr. Christopher Randolph, PhD, ABPP-CN | Chief Scientific Officer