Enrichment of MCI and early Alzheimer's disease treatment trials using neurochemical and imaging candidate biomarkers.

Hdl Handle:
http://hdl.handle.net/10147/207893
Title:
Enrichment of MCI and early Alzheimer's disease treatment trials using neurochemical and imaging candidate biomarkers.
Authors:
Hampel, H; Broich, K
Affiliation:
Discipline of Psychiatry, School of Medicine, Trinity College, University of, Dublin, Trinity Center for Health Sciences, The Adelaide and Meath Hospital, incorporating the National Children's Hospital (AMiNCH), Tallaght, Dublin 24,, Ireland. harald.hampel@tcd.ie
Citation:
J Nutr Health Aging. 2009 Apr;13(4):373-5.
Journal:
The journal of nutrition, health & aging
Issue Date:
1-Feb-2012
URI:
http://hdl.handle.net/10147/207893
PubMed ID:
19300885
Abstract:
In the earliest clinical stages of Alzheimer's Disease (AD), when symptoms are mild, clinical diagnosis will still be difficult. AD related molecular mechanisms precede symptoms. Biological markers can serve as early diagnostic indicators, as markers of preclinical pathological change, e.g. underlying mechanisms of action (MoA). Hypothesis based candidates are derived from structural and functional neuroimaging as well as from cerebrospinal fluid (CSF) and plasma. Unbiased exploratory approaches e.g. proteome analysis or rater independent fully automated imaging post-processing methods yield novel candidates. Recent progress in the validation of core feasible imaging and neurochemical biomarkers for functions such as early detection, classification, progression and prediction of AD is summarized. Single core feasible biomarkers can already be used to enrich populations at risk for AD and may be further enhanced using distinct combinations. Some biomarkers are currently in the process of implementation as primary or secondary outcome variables into regulatory guideline documents, e.g. regarding phase II in drug development programs as outcome measures in proof of concept or dose finding studies. There are specific biomarkers available depending on the hypothesized mechanism of action of a medicinal product, e.g. impact on the amyloidogenic cascade or on tauhyperphosphorylation. Ongoing large-scale international controlled multi-center trials will provide further validation of selected core feasible imaging and CSF biomarker candidates as outcome measures in early AD for use in phase III clinical efficacy trials. There is a need of rigorous co-development of biological trait- and statemarker candidates facilitated through planned synergistic collaboration between academic, industrial and regulatory partners.
Language:
eng
MeSH:
*Alzheimer Disease/cerebrospinal fluid/pathology/radionuclide imaging; Biological Markers/*analysis; Cognition Disorders/cerebrospinal fluid/pathology/radionuclide imaging; Early Diagnosis; Humans; Magnetic Resonance Imaging/methods; Positron-Emission Tomography/methods; Research Design
ISSN:
1279-7707 (Print); 1279-7707 (Linking)

Full metadata record

DC FieldValue Language
dc.contributor.authorHampel, Hen_GB
dc.contributor.authorBroich, Ken_GB
dc.date.accessioned2012-02-01T10:49:20Z-
dc.date.available2012-02-01T10:49:20Z-
dc.date.issued2012-02-01T10:49:20Z-
dc.identifier.citationJ Nutr Health Aging. 2009 Apr;13(4):373-5.en_GB
dc.identifier.issn1279-7707 (Print)en_GB
dc.identifier.issn1279-7707 (Linking)en_GB
dc.identifier.pmid19300885en_GB
dc.identifier.urihttp://hdl.handle.net/10147/207893-
dc.description.abstractIn the earliest clinical stages of Alzheimer's Disease (AD), when symptoms are mild, clinical diagnosis will still be difficult. AD related molecular mechanisms precede symptoms. Biological markers can serve as early diagnostic indicators, as markers of preclinical pathological change, e.g. underlying mechanisms of action (MoA). Hypothesis based candidates are derived from structural and functional neuroimaging as well as from cerebrospinal fluid (CSF) and plasma. Unbiased exploratory approaches e.g. proteome analysis or rater independent fully automated imaging post-processing methods yield novel candidates. Recent progress in the validation of core feasible imaging and neurochemical biomarkers for functions such as early detection, classification, progression and prediction of AD is summarized. Single core feasible biomarkers can already be used to enrich populations at risk for AD and may be further enhanced using distinct combinations. Some biomarkers are currently in the process of implementation as primary or secondary outcome variables into regulatory guideline documents, e.g. regarding phase II in drug development programs as outcome measures in proof of concept or dose finding studies. There are specific biomarkers available depending on the hypothesized mechanism of action of a medicinal product, e.g. impact on the amyloidogenic cascade or on tauhyperphosphorylation. Ongoing large-scale international controlled multi-center trials will provide further validation of selected core feasible imaging and CSF biomarker candidates as outcome measures in early AD for use in phase III clinical efficacy trials. There is a need of rigorous co-development of biological trait- and statemarker candidates facilitated through planned synergistic collaboration between academic, industrial and regulatory partners.en_GB
dc.language.isoengen_GB
dc.subject.mesh*Alzheimer Disease/cerebrospinal fluid/pathology/radionuclide imagingen_GB
dc.subject.meshBiological Markers/*analysisen_GB
dc.subject.meshCognition Disorders/cerebrospinal fluid/pathology/radionuclide imagingen_GB
dc.subject.meshEarly Diagnosisen_GB
dc.subject.meshHumansen_GB
dc.subject.meshMagnetic Resonance Imaging/methodsen_GB
dc.subject.meshPositron-Emission Tomography/methodsen_GB
dc.subject.meshResearch Designen_GB
dc.titleEnrichment of MCI and early Alzheimer's disease treatment trials using neurochemical and imaging candidate biomarkers.en_GB
dc.contributor.departmentDiscipline of Psychiatry, School of Medicine, Trinity College, University of, Dublin, Trinity Center for Health Sciences, The Adelaide and Meath Hospital, incorporating the National Children's Hospital (AMiNCH), Tallaght, Dublin 24,, Ireland. harald.hampel@tcd.ieen_GB
dc.identifier.journalThe journal of nutrition, health & agingen_GB
dc.description.provinceLeinster-

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