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Open Access Highly Accessed Study protocol

Diagnostic and economic evaluation of new biomarkers for Alzheimer’s disease: the research protocol of a prospective cohort study

Ron LH Handels1, Pauline Aalten1, Claire AG Wolfs1, Marcel OldeRikkert2, Philip Scheltens3, Pieter Jelle Visser13, Manuela A Joore4, Johan L Severens45 and Frans RJ Verhey16*

Author Affiliations

1 Alzheimer Centre Limburg, School for Mental Health and Neuroscience (MHeNS), University Medical Centre, P.O. Box 5800, 6202, AZ, Maastricht, the Netherlands

2 Alzheimer Centre Nijmegen, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

3 Alzheimer Centre, Department of Neurology, VU University Medical Centre, Amsterdam, the Netherlands

4 Maastricht University, CAPHRI School for Public Health and Primary Care, Faculty of Health Medicine and Life Sciences, Department of Health Organization, Policy and Economics, P.O. Box 616, 6200, MD, Maastricht, the Netherlands

5 Institute of Health Policy and Management, Erasmus University Rotterdam, P.O. Box 1738, 3000, DR, Rotterdam, The Netherlands

6 Department of Psychiatry and Neuropsychology, University Hospital of Maastricht/Alzheimer Centre Limburg, P.O. Box 5800, 6202, AZ, Maastricht, The Netherlands

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BMC Neurology 2012, 12:72  doi:10.1186/1471-2377-12-72

Published: 10 August 2012

Abstract

Background

New research criteria for the diagnosis of Alzheimer’s disease (AD) have recently been developed to enable an early diagnosis of AD pathophysiology by relying on emerging biomarkers. To enable efficient allocation of health care resources, evidence is needed to support decision makers on the adoption of emerging biomarkers in clinical practice. The research goals are to 1) assess the diagnostic test accuracy of current clinical diagnostic work-up and emerging biomarkers in MRI, PET and CSF, 2) perform a cost-consequence analysis and 3) assess long-term cost-effectiveness by an economic model.

Methods/design

In a cohort design 241 consecutive patients suspected of having a primary neurodegenerative disease are approached in four academic memory clinics and followed for two years. Clinical data and data on quality of life, costs and emerging biomarkers are gathered.

Diagnostic test accuracy is determined by relating the clinical practice and new research criteria diagnoses to a reference diagnosis. The clinical practice diagnosis at baseline is reflected by a consensus procedure among experts using clinical information only (no biomarkers). The diagnosis based on the new research criteria is reflected by decision rules that combine clinical and biomarker information. The reference diagnosis is determined by a consensus procedure among experts based on clinical information on the course of symptoms over a two-year time period.

A decision analytic model is built combining available evidence from different resources among which (accuracy) results from the study, literature and expert opinion to assess long-term cost-effectiveness of the emerging biomarkers.

Discussion

Several other multi-centre trials study the relative value of new biomarkers for early evaluation of AD and related disorders. The uniqueness of this study is the assessment of resource utilization and quality of life to enable an economic evaluation. The study results are generalizable to a population of patients who are referred to a memory clinic due to their memory problems.

Trial registration

NCT01450891