With the evolving pharmacological era for the treatment of Alzheimer's disease (AD), there is a growing urgency to develop biochemical markers, as well as biomarkers based on imaging techniques to aid early accurate diagnosis, characterize patient populations and quantify the extent to which new drugs reach intended targets, alter proposed pathophysiological mechanisms and achieve clinical outcomes. Biomarkers support stratification of patient populations or quantification of drug benefit in primary prevention or disease-modification studies. Enrichment of trials with patients with similar prognosis according to a particular biomarker or combination of biomarkers could speed up proof-of-concept and dose-ranging studies. A wide range of imaging-based biomarkers are presently being studied for AD. These include an ever growing array of manual or fully automated MRI post-processing techniques of whole brain, grey or white matter, fiber tracts or specific brain regions, as well as metabolic, functional MRI and PET investigations. Multiple biochemical analytes in blood, urine or cerebrospinal fluid (CSF) have been proposed and studied, the most obvious of which are CSF β-amyloid related proteins, including abeta-antibodies and BACE 1, or tau proteins (total and phosphorylated tau), as they seem intimately involved in key mechanisms of AD. However, there are many different therapeutic approaches predicated on different pathophysiological hypotheses that might require different mechanistic markers. It is therefore likely that a multi-modal biomarker approach stratified for ease of use, sensitivity and specificity will be needed in AD. This paper will focus on advances in the development of an immunotherapy for AD. In summary, clinically useful biochemical and imaging derived markers are clearly required in AD to inform regulatory and therapeutic decision making regarding candidate drugs and their indications in order to help bring new medicines to the right patients faster than they are today. Clearly, for AD a good biomarker could significantly reduce drug development timelines and optimize resources, thereby facilitating the evaluation of multiple molecules and therapeutic approaches. Currently, biomarkers, as well as novel therapeutic strategies need to be simultaneously developed and synergistically implemented in clinical AD research.