The importance of age effects on performance in the assessment of clinical trials

Abstract

Forty young adult normal subjects, 10 Parkinson's disease patients and their 10 matched normal subjects, and 10 multiple sclerosis patients and their 10 matched normal subjects were evaluated in the Quantitative Examination of Neurological Function to determine age effects and the importance of selecting closely matched normal control groups for assessing the performance of patients. Where there are significant differences among the three normal subject groups, it is the oldest normal subject group that differs from the two younger subject groups. Significant decreases in performance with increasing age were found for the steadiness tests performed in the supported position, the sensation tests, two or five tests in the Neuro-Psychological Examination and tests requiring fine skilled movements primarily with the dominant hand. It was found that older subjects made fewer errors in coordinated tasks. A normalization technique, expressing performance as a percentage of normal function, was introduced. A method was developed to provide quantitative and meaningful indices of neurological function. The measure is obtained by averaging the percentage of normal function scores over several tests that belong to a primary category of neurological function. Young adult normal subjects do not perform significantly better than normal subjects in the age range of multiple sclerosis patients; however, young adult normal subjects do perform significantly better than normal subjects in the age range of Parkinson's disease patients, especially on tasks requiring fine skilled movements of the dominant hand and coordinated activities of the lower extremities. These results indicate that the performance of multiple sclerosis patients can be expressed as a percentage of the function of either age-matched normal controls or young adult normal controls. However, the performance of Parkinson's disease patients should be expressed only as a percentage of the function of age-matched normal controls.