Premium
Commentary on “Biomarkers in Alzheimer's disease drug development.” The view from Alzheimer's Disease Neuroimaging Initiative
Author(s) -
Weiner Michael W.
Publication year - 2011
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2010.06.005
Subject(s) - library science , alzheimer's disease neuroimaging initiative , citation , veterans affairs , neuroimaging , gerontology , psychology , medicine , disease , computer science , alzheimer's disease , psychiatry , pathology
1552 doi:1 ‘‘Biomarkers in preclinical testing assist in decisions to develop an agent. Biomarkers in Phase I provide insight into toxic responses and drug metabolism. Biomarkers in Phase II proof-of-concept trials facilitate go/no-go decisions and dose finding. Biomarkers can play a role in identifying presymptomatic patients or specific patient subgroups. They can provide evidence of target engagement before clinical changes can be expected. .Surrogate markers that can function as outcomes in pivotal trials and reliably predict clinical outcomes are needed to facilitate primary prevention trials of asymptomatic persons.’’