A framework for selection of blood-based biomarkers for geroscience-guided clinical trials: report from the TAME Biomarkers Workgroup

Recent advances indicate that biological aging is a potentially modifiable driver of late-life function and chronic disease and have led to the development of geroscience-guided therapeutic trials such as TAME (Targeting Aging with MEtformin). TAME is a proposed randomized clinical trial using metfo...

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Vydané v:GeroScience Ročník 40; číslo 5-6; s. 419 - 436
Hlavní autori: Justice, Jamie N., Ferrucci, Luigi, Newman, Anne B., Aroda, Vanita R., Bahnson, Judy L., Divers, Jasmin, Espeland, Mark A., Marcovina, Santica, Pollak, Michael N., Kritchevsky, Stephen B., Barzilai, Nir, Kuchel, George A.
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Cham Springer International Publishing 01.12.2018
Springer Nature B.V
Predmet:
Age differences
Aging
Aging - blood
Antidiabetics
Biological markers
Biology
Biomarkers
Biomarkers - blood
Biomedical and Life Sciences
Biomedical Research
Blood
Candidates
Cell Biology
Chronic illnesses
Clinical research
Clinical trials
Criteria
Cystatin C
Disease
Feasibility
Frame analysis
Functional impairment
Geriatrics/Gerontology
Hemoglobin
Humans
Hypoglycemic Agents - therapeutic use
Insulin
Insulin-like growth factor I
Interleukin 6
Intervention
Life Sciences
Literature
Literature reviews
Measurement
Medical diagnosis
Metformin
Metformin - therapeutic use
Molecular Medicine
Morbidity
Randomized Controlled Trials as Topic
Reliability
Reproducibility of Results
Responsiveness
Review
Review Article
Scarcity
Selection criteria
Tumor necrosis factor-α
Mortality
Biomarkers
Aging
Inflammation
Metformin
Randomized controlled trial
Epidemiology
ISSN:2509-2715, 2509-2723, 2509-2723
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Shrnutí:Recent advances indicate that biological aging is a potentially modifiable driver of late-life function and chronic disease and have led to the development of geroscience-guided therapeutic trials such as TAME (Targeting Aging with MEtformin). TAME is a proposed randomized clinical trial using metformin to affect molecular aging pathways to slow the incidence of age-related multi-morbidity and functional decline. In trials focusing on clinical end-points (e.g., disease diagnosis or death), biomarkers help show that the intervention is affecting the underlying aging biology before sufficient clinical events have accumulated to test the study hypothesis. Since there is no standard set of biomarkers of aging for clinical trials, an expert panel was convened and comprehensive literature reviews conducted to identify 258 initial candidate biomarkers of aging and age-related disease. Next selection criteria were derived and applied to refine this set emphasizing: (1) measurement reliability and feasibility; (2) relevance to aging; (3) robust and consistent ability to predict all-cause mortality, clinical and functional outcomes; and (4) responsiveness to intervention. Application of these selection criteria to the current literature resulted in a short list of blood-based biomarkers proposed for TAME: IL-6, TNFα-receptor I or II, CRP, GDF15, insulin, IGF1, cystatin C, NT-proBNP, and hemoglobin A1c. The present report provides a conceptual framework for the selection of blood-based biomarkers for use in geroscience-guided clinical trials. This work also revealed the scarcity of well-vetted biomarkers for human studies that reflect underlying biologic aging hallmarks, and the need to leverage proposed trials for future biomarker discovery and validation.
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ISSN:2509-2715
2509-2723
2509-2723
DOI:10.1007/s11357-018-0042-y