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        Image-Based Biomarkers in Alzheimers Disease, 2011
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Summary

This report provides an overview of image-based biomarkers associated with Alzheimer’s disease
(AD), that have potential in differential diagnosis, in following treatment, in clinical trials and drug
discovery.

AD biomarkers offer utility in a number of ways: identification of groups at risk of developing AD;
early detection of AD; differentiation of different forms of neurodegenerative disease from AD, as well
as developmental stages (such as MCI), thought to progress to AD; supporting specific treatments or
pharmacological interventions; following the time-course progression of AD and response to therapy;
assessing patient prognosis; advancing understanding of the disease, including risk factors, and the
changes that precede its development; the identification of new drug targets and candidate molecules;
development of discovery assays for efficacy or toxicity markers; and supporting the recruitment of
subjects most likely to provide a meaningful analysis of treatment effects. These areas are, therefore,
considered and discussed in relation to the AD biomarkers presented in this report.

Of the biomarker areas being researched, the goal of developing methods for the early detection of
AD, including the prediction of risk in particular patient groups, is a key priority. It is believed that the
first symptoms of AD – generally diagnosed using cognitive, behavioral and functional assessments –
occur after significant neuronal loss has already occurred. Consequently, it is thought that patients
diagnosed at this stage will be less likely to gain benefits from treatment. This also hampers the
development of disease-altering therapies, because, without adequate comparators (e.g. showing
those who have the disease, or a particular developmental stage such as MCI, compared to healthy
controls), it is difficult or impossible to evaluate treatment effects. Therefore, in the preparation of this
report, emphasis was given to identifying biomarkers with potential in the early detection of the
disease, or alternatively, in differentiating different stages or types of neurodegenerative disease,
thought to be related to AD.

This Report

There are many AD biomarker studies; a report of this nature can provide only a general overview.
More than 750 studies have been reviewed in its preparation (up to January 2011), and the findings
from a short-list of approximately 150 studies are presented and discussed. The key goals of this
report are practical in nature – to identify biomarkers that show the greatest potential in advancing
research and development in the diagnosis and treatment of AD. The goals are as follows:
a) to review studies published over the last decade (up to Jan 2011) for short-listing;
b) to identify controlled clinical studies relating to AD and/or neurodegenerative conditions or stages
believed to precede AD (e.g. MCI), that included the study of biomarkers (blood, CSF, genetic, image-
based and others NB: this report presents only findings relating to image-based biomarkers); and
c) to short-list opportunities to develop tests in the areas of utility indicated, with a particular
emphasis on the early detection of AD or following disease progression.

Table of Contents:
Index Page
Chapter 1 Background 18
1. Alzheimer’s Disease 19
1.1 Statistics and Costs 19
1.2 Histopathology 20
1.3 Amyloid Beta (Abeta) 20
1.4 Tau Proteins and Neurofibrillary Tangles 21
1.5 Cholinergic Hypothesis 22
1.6 Diagnosis 22
1.7 Cognitive Tests 23
1.8 Stages of Alzheimer’s Disease 25
1.9 Treatment of AD 25
1.10 Biomarkers 26
1.11 Genetics 27

Chapter 2 Image-Based Biomarkers 33-52
Chapter 3 Discussion 54-61

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