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.

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.

Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.2K
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.7K
Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
1.4K
Trial and Error and Algorithm01:12

Trial and Error and Algorithm

A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
404
Gravitational Potential Energy for Extended Objects01:07

Gravitational Potential Energy for Extended Objects

Consider a system comprising several point masses. The coordinates of the center of mass for this system can be expressed as the summation of the product of each mass and its position vector divided by the total mass:
1.9K
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
146