As the field of Alzheimer’s disease (AD) moves toward early detection and prevention, the need for outcome measures that are sensitive to subtle changes in early AD has become increasingly important.
The ADAS-Cog has been proven to suffer from ceiling effects in clinical trials in MCI subjects, and has been insensitive to the measurement of disease progression in placebo arms of trials of 1-2 years in duration.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is an instrument that has been used both as an inclusion measure in clinical trials of MCI and as an endpoint in prevention trials.
While the CDR-SB is most often used as the primary endpoint in MCI trials, there is no consensus on the most suitable endpoint for measuring neurocognition in these trials.
The goal of the present study was to examine the potential utility of the RBANS in prodromal AD trials. Specifically, we investigated the extent to which the RBANS correlated with, and was sensitive to range of the CDR-SB in an MCI population.
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