Evaluation of selection criteria used in Alzheimer's disease clinical trials

The Canadian Journal of Neurological Sciences. Le Journal Canadien Des Sciences Neurologiques
J Willmer, E Mohr

Abstract

In the absence of a biological marker for Alzheimer's disease (AD), diagnosis has to be achieved using clinical criteria sets such as those outlined in DSM-IV, NINCDS-ADRDA, or ICD-10. As these criteria are quite broadly defined, there may be inter-rater variability in interpretation. Using a previously published CT scan measuring technique which correlates well with diagnoses achieved using the NINCDS-ADRDA criteria as interpreted at our clinic, we chose to independently examine and reach a diagnosis in patients selected for participation in clinical trials of therapeutic agents for the treatment of AD. Forty-four CT scans from six investigators across Canada were examined using this model. All patients had been diagnosed as having AD by NINCDS-ADRDA criteria and were deemed acceptable to participate in a clinical trial. The diagnostic concordance achieved in the original published model was 91.5%. The diagnostic concordance in the population currently being studied was 77.3%. However when examined by site, results ranged from 57.1% to 100%. Using the model, an index of atrophy and a probability of diagnosis of AD can be determined. Across sites, there were statistically significant differences in these measures (p < or = 0.03...Continue Reading

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