The role of biomarkers in clinical trials for Alzheimer disease

Leon J. Thal, Kejal Kantarci, Eric M. Reiman, William E. Klunk, Michael W. Weiner, Henrik Zetterberg, Douglas Galasko, Domenico Praticò, Sue Griffin, Dale Schenk, Eric Siemers

Research output: Contribution to journalReview articlepeer-review

187 Scopus citations


Biomarkers are likely to be important in the study of Alzheimer disease (AD) for a variety of reasons. A clinical diagnosis of Alzheimer disease is inaccurate even among experienced investigators in about 10% to 15% of cases, and biomarkers might improve the accuracy of diagnosis. Importantly for the development of putative disease-modifying drugs for Alzheimer disease, biomarkers might also serve as indirect measures of disease severity. When used in this way, sample sizes of clinical trials might be reduced, and a change in biomarker could be considered supporting evidence of disease modification. This review summarizes a meeting of the Alzheimer's Association's Research Roundtable, during which existing and emerging biomarkers for AD were evaluated. Imaging biomarkers including volumetric magnetic resonance imaging and positron emission tomography assessing either glucose utilization or ligands binding to amyloid plaque are discussed. Additionally, biochemical biomarkers in blood or cerebrospinal fluid are assessed. Currently appropriate uses of biomarkers in the study of Alzheimer disease, and areas where additional work is needed, are discussed.

Original languageEnglish (US)
Pages (from-to)6-15
Number of pages10
JournalAlzheimer disease and associated disorders
Issue number1
StatePublished - Jan 2006


  • Alzheimer disease
  • Amyloid beta
  • Cerebrospinal fluid
  • Clinical trials
  • Cytokines
  • Isoprostanes
  • Positron emission tomography
  • Tau
  • Volumetric magnetic resonance imaging

ASJC Scopus subject areas

  • Clinical Psychology
  • Gerontology
  • Geriatrics and Gerontology
  • Psychiatry and Mental health


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