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Updated: Jan 27, 2026

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Development of Clinical Trials to Extend Healthy Lifespan
Jamie N Justice1, Laura Niedernhofer2, Paul D Robbins2
1Internal Medicine Section on Gerontology and Geriatrics, and the Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.
Abstract:
Significant progress in defining the biology of aging, particularly in animal models, supports the geroscience hypothesis, which posits that by therapeutically targeting biological aging, the onset of multiple age-related diseases can be delayed "en suite". Geroscience investigators are preparing to test this hypothesis in humans for the first time. In this review, we describe development of large-scale clinical trials designed to determine if multiple age-related health conditions can be simultaneously alleviated with interventions targeting the underlying biology of aging. We describe the rationale and collaborative, consensus building approach used to design the first aging outcomes trial called Targeting Aging with Metformin (TAME). Through this case study, we outline features that could be more broadly extended to other geroscience-guided clinical trials, including a process for selecting biochemical and molecular markers of biologic age and we provide a perspective on the potential impact of clinical trials targeting aging.
Insights
Scientists are testing the geroscience hypothesis in humans, aiming to delay multiple age-related diseases by targeting the biology of aging. The Targeting Aging with Metformin (TAME) trial is a key step in this research.
Area of Science:
- Gerontology and Gerontechnology
- Translational Medicine
- Biomedical Gerontology
Background:
- The geroscience hypothesis suggests targeting biological aging can delay multiple age-related diseases.
- Significant progress in animal models supports this hypothesis, paving the way for human trials.
Purpose of the Study:
- To describe the development of large-scale clinical trials testing the geroscience hypothesis in humans.
- To outline the rationale and design of the Targeting Aging with Metformin (TAME) trial as a case study.
- To provide a perspective on the potential impact of clinical trials targeting aging.
Main Methods:
- Review of the development of clinical trials designed to test the geroscience hypothesis.
- Description of the collaborative, consensus-building approach for designing the TAME trial.
- Outline of a process for selecting biomarkers of biological age for geroscience trials.
Main Results:
- The TAME trial is the first large-scale clinical trial designed to test the geroscience hypothesis in humans.
- The trial aims to determine if interventions targeting aging biology can alleviate multiple age-related health conditions simultaneously.
- A framework for selecting biomarkers of aging is being developed.
Conclusions:
- Human trials are now feasible to test the geroscience hypothesis.
- The TAME trial serves as a model for future geroscience-guided clinical trials.
- Targeting biological aging holds potential for simultaneously delaying multiple age-related diseases.
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