期刊
ALZHEIMERS & DEMENTIA
卷 11, 期 1, 页码 58-69出版社
WILEY
DOI: 10.1016/j.jalz.2014.02.004
关键词
Cerebrospinal fluid; Biomarkers; Alzheimer's disease; beta-Amyloid; Tau protein; Mild cognitive impairment
资金
- Biomarkers for Alzheimer's disease and Parkinson's disease (BIOMARKAPD)
- Katharina-Hardt-Foundation, Bad Homburg, Germany
- Fondation Pour La Recherche Sur Alzheimer (FRA), Paris, France
- National Institute on Aging [P01AG026276]
- Hope Centre for Neurological Disorders
- German Bundesministerium fur Bildung und Forschung [01ED1203D]
- BiomarkAPD Project of the JPND
- NIH-NIA
- Roche Diagnostics International Ltd
Several potential disease-modifying drugs for Alzheimer's disease (AD) have failed to show any effect on disease progression in clinical trials, conceivably because the AD subjects are already too advanced to derive clinical benefit from treatment and because diagnosis based on clinical criteria alone introduces a high misdiagnosis rate. Thus, well-validated biomarkers for early detection and accurate diagnosis are crucial. Low cerebrospinal fluid (CSF) concentrations of the amyloid-beta (A beta(1-42)) peptide, in combination with high total tau and phosphorylated tau, are sensitive and specific biomarkers highly predictive of progression to AD dementia in patients with mild cognitive impairment. However, interlaboratory variations in the results seen with currently available immunoassays are of concern. Recent worldwide standardization efforts and quality control programs include standard operating procedures for both preanalytical (e.g., lumbar puncture and sample handling) and analytical (e.g., preparation of calibration curve) procedures. Efforts are also ongoing to develop highly reproducible assays on fully automated instruments. These global standardization and harmonization measures will provide the basis for the 'generalized international application of CSF biomarkers for both clinical trials and routine clinical diagnosis of AD. (C) 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.
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