@article{8cfaa2905aac4b92ab022445dda1855e,
title = "Clinical validity of medial temporal atrophy as a biomarker for Alzheimer's disease in the context of a structured 5-phase development framework",
abstract = "Research criteria for Alzheimer's disease recommend the use of biomarkers for diagnosis, but whether biomarkers improve the diagnosis in clinical routine has not been systematically assessed. The aim is to evaluate the evidence for use of medial temporal lobe atrophy (MTA) as a biomarker for Alzheimer's disease at the mild cognitive impairment stage in routine clinical practice, with an adapted version of the 5-phase oncology framework for biomarker development. A literature review on visual assessment of MTA and hippocampal volumetry was conducted with other biomarkers addressed in parallel reviews. Ample evidence is available for phase 1 (rationale for use) and phase 2 (discriminative ability between diseased and control subjects). Phase 3 (early detection ability) is partly achieved: most evidence is derived from research cohorts or clinical populations with short follow-up, but validation in clinical mild cognitive impairment cohorts is required. In phase 4, only the practical feasibility has been addressed for visual rating of MTA. The rest of phase 4 and phase 5 have not yet been addressed.",
keywords = "Alzheimer's disease, Dementia, Hippocampus, MRI, Medial temporal lobe atrophy, Mild cognitive impairment, Roadmap",
author = "{ten Kate}, Mara and Frederik Barkhof and Marina Boccardi and Visser, {Pieter Jelle} and Jack, {Clifford R.} and Lovblad, {Karl Olof} and Frisoni, {Giovanni B.} and Philip Scheltens",
note = "Funding Information: The following scientific societies took part to the Geneva Workshop for the Roadmap of Alzheimer's Biomarkers on December 8–9, 2014. Flavio Nobili was delegate from the European Association of Nuclear Medicine (EANM) Neuroimaging Committee. Kaj Blennow was a delegate and Chair of the International Federation of Clinical Chemistry and Laboratory Medicine Working Group for CSF proteins (IFCC WG-CSF). Frederik Barkhof was delegate from the European Society of Neuroradiology (ESNR). Stefano Cappa was a delegate and Chair of the Federation of European Societies of Neuropsychology (FENS). Urs Mosimann was a delegate from the Swiss Federation of Clinical Neuro Societies (SFCNS). The content of this article represents the opinion of the individual authors and is not necessarily endorsed by the scientific societies which took part to the Geneva Workshop for the Roadmap of Alzheimer's Biomarkers, except the ESNR which formally endorsed it on September 5th, 2015. The first author has received support from the EU/EFPIA Innovative Medicines Initiative Joint Undertaking (EMIF grant: 115372). The VUmc Alzheimer center is supported by Alzheimer Nederland and Stichting VUmc fonds. Dr. Visser reports grants from EU/EFPIA Innovative Medicines Initiative Joint Undertaking, grants from EU Joint Programme–Neurodegenerative Disease Research (JPND), and ZonMw, during the conduct of the study; others from Roche Diagnostics and grants from Bristol-Myers Squibb. Dr. Frisoni received research grants from Wyeth Int'l, Lilly Int'l, Lundbeck Italia, GE Int'l, Avid/Lilly, Roche, Piramal, and the Alzheimer's Association. Dr. Boccardi received a research grant from Piramal. Dr. Scheltens has received grant support (for the institution) from GE Healthcare, Danone Research, Piramal, and MERCK. Dr. Jack receives research funding from the National Institutes of Health (R01-AG011378, RO1 AG041851, U01-AG06786, U01-AG024904, R01 AG37551, R01AG043392). Publisher Copyright: {\textcopyright} 2016 Elsevier Inc.",
year = "2017",
month = apr,
day = "1",
doi = "10.1016/j.neurobiolaging.2016.05.024",
language = "English (US)",
volume = "52",
pages = "167--182.e1",
journal = "Neurobiology of Aging",
issn = "0197-4580",
publisher = "Elsevier Inc.",
}