TY - JOUR
T1 - Blood-based biomarkers for Alzheimer disease
T2 - mapping the road to the clinic
AU - Hampel, Harald
AU - O’Bryant, Sid E.
AU - Molinuevo, José L.
AU - Zetterberg, Henrik
AU - Masters, Colin L.
AU - Lista, Simone
AU - Kiddle, Steven J.
AU - Batrla, Richard
AU - Blennow, Kaj
N1 - Publisher Copyright:
© 2018, Springer Nature Limited.
PY - 2018/11/1
Y1 - 2018/11/1
N2 - Biomarker discovery and development for clinical research, diagnostics and therapy monitoring in clinical trials have advanced rapidly in key areas of medicine — most notably, oncology and cardiovascular diseases — allowing rapid early detection and supporting the evolution of biomarker-guided, precision-medicine-based targeted therapies. In Alzheimer disease (AD), breakthroughs in biomarker identification and validation include cerebrospinal fluid and PET markers of amyloid-β and tau proteins, which are highly accurate in detecting the presence of AD-associated pathophysiological and neuropathological changes. However, the high cost, insufficient accessibility and/or invasiveness of these assays limit their use as viable first-line tools for detecting patterns of pathophysiology. Therefore, a multistage, tiered approach is needed, prioritizing development of an initial screen to exclude from these tests the high numbers of people with cognitive deficits who do not demonstrate evidence of underlying AD pathophysiology. This Review summarizes the efforts of an international working group that aimed to survey the current landscape of blood-based AD biomarkers and outlines operational steps for an effective academic–industry co-development pathway from identification and assay development to validation for clinical use.
AB - Biomarker discovery and development for clinical research, diagnostics and therapy monitoring in clinical trials have advanced rapidly in key areas of medicine — most notably, oncology and cardiovascular diseases — allowing rapid early detection and supporting the evolution of biomarker-guided, precision-medicine-based targeted therapies. In Alzheimer disease (AD), breakthroughs in biomarker identification and validation include cerebrospinal fluid and PET markers of amyloid-β and tau proteins, which are highly accurate in detecting the presence of AD-associated pathophysiological and neuropathological changes. However, the high cost, insufficient accessibility and/or invasiveness of these assays limit their use as viable first-line tools for detecting patterns of pathophysiology. Therefore, a multistage, tiered approach is needed, prioritizing development of an initial screen to exclude from these tests the high numbers of people with cognitive deficits who do not demonstrate evidence of underlying AD pathophysiology. This Review summarizes the efforts of an international working group that aimed to survey the current landscape of blood-based AD biomarkers and outlines operational steps for an effective academic–industry co-development pathway from identification and assay development to validation for clinical use.
UR - http://www.scopus.com/inward/record.url?scp=85054570892&partnerID=8YFLogxK
U2 - 10.1038/s41582-018-0079-7
DO - 10.1038/s41582-018-0079-7
M3 - Review article
C2 - 30297701
AN - SCOPUS:85054570892
SN - 1759-4758
VL - 14
SP - 639
EP - 652
JO - Nature Reviews Neurology
JF - Nature Reviews Neurology
IS - 11
ER -