BASIC AND CLINICAL-STUDIES ON THE MEASUREMENT OF TAU-PROTEIN IN CEREBROSPINAL-FLUID AS A BIOLOGICAL MARKER FOR ALZHEIMERS-DISEASE AND RELATED DISORDERS - MULTICENTER STUDY IN JAPAN

The development of a diagnostic marker for earlier and more accurate c linical diagnosis of Alzheimer's disease (AD) is essential to identify AD patients during life unequivocally. The purpose of this study was to investigate the basic performance and clinical significance of tau level measurement in the cerebrospinal fluid (CSF) using an enzyme-lin ked immunosorbent assay (ELISA) developed by Innogenetics. The ELISA s ystem showed reliable reproducibility and good linearity. For clinical studies, the CSF samples from a variety of patients (n = 332) were ex amined. They were classified into the Sour groups: Alzheimer's disease (AD); neurodegenerative diseases (ND); cerebrovascular diseases (VD); and a neurological control (NC) group. The CSF-tau levels for AD, ND, VD and NC were 426 +/- 234 pg/ml, 239 +/- 157 pg/ml, 216 +/- 136 pg/m l, and 188 +/- 103 pg/ml, respectively. The CSF-tale level of the AD g roup was significantly higher than that of the other groups (p < 0.001 ). The CSF-tau levels increased during follow-up. The measurement of t he tau level in CSF is shown to be a useful marker io confirm a clinic al diagnosis of AD. (C) 1998 Prous Science. All rights reserved.