The TAME Trial Will Change Ageing Research Forever (Even if it Does Not Work)

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Targeting Ageing with Metformin – TAME – Goals and Controversy

The TAME trial is focused on Metformin, which has been prescribed to treat Type 2 Diabetes since the 1950’s.

In 2014, a retrospective study by researchers at the University of Cardiff showed that people taking it had a lower mortality and fewer of the chronic diseases of old age.

Counterintuitively, people with Type 2 Diabetes taking Metformin outlived people without this condition who were not taking it. On average, Type 2 Diabetes sufferers are more likely to be overweight and to have other chronic diseases.

This finding got the attention of researchers from around the world.

Dr Nir Barzilai took things further – creating the ‘TAME’ study.

This acronym stands for ‘Target of Aging Metformin.’ In a double-blind placebo controlled clinical trial, 3000 people aged 65 to 80 will be studied over a period of 6 years.

The objectives of TAME are two-fold:

  • Assessment of the incidence of a cluster of age-related diseases.
  • Tracking biomarkers associated with ageing.

This study is part funded by the American Federation of Aging Research, and partly through private donations. The $75 million cost has caused significant controversy.

Metformin and Aging Test

FDA Approval for the TAME Trial

The fact that aging is not categorised as a disease is more than just semantics.

Without this classification, US healthcare providers can’t bill drug companies. Without that income stream, there is little incentive for pharmaceutical giants to invest in research.

What is different about TAME is that the FDA (US Food and Drug Administration) have given the go-ahead for a trial that specifically targets ageing biomarkers.

This is the first time a general treatment for biological ageing has been approved for clinical trial.

It will open the door to future trials. If it shows promise, then the funding for development and trials for other promising drugs would accelerate.

Controversy: Is TAME a Waste of $75 Million?

On the surface, TAME looks like the breakthrough longevity researchers have been waiting for.

Not so fast.

The funding for this study has divided opinion.

Aubrey de Grey has called it a waste of money. He states that Metformin has negligible results for ageing compared to other compounds. That money spent studying Rapamycin, Querectin or Senolytics would be better spent. de Grey is not alone. Scan the comments of any video, tweet or news article on TAME and you’ll quickly see that this study is a hot-button issue.

Side-effects of Metformin have been singled out too. Decrease in aerobic function is a known drawback (Metformin triggers scarcity mimetic pathways). Requirements to supplement B12 and B6 are also catalogued.

Metformin and the TAME trial

Metformin: Clinical Evidence

Benefits of Metformin demonstrated in clinical trial data have been accumulating for decades. Dr Barzilai addresses many of these (and explains the TAME trial) in the video below. First, here are some selected highlights:

  • Significantly lower morbidity among diabetics taking Metformin.
  • Measurable reduction in diabetes.
  • Prevention of cardiovascular disease.
  • Associations with lower cancer incidence (more trials needed)
  • Slows cognitive decline

Results of the TAME Trial

I’m looking forward to following the results of the TAME study. You can sign up to get e-mail alerts, via a link on this page.

As for the controversy? I’m positive on this trial.

Millions of people over 50+ years use Metformin. It is both safe and effective.

If the FDA is ever going to green light a clinical trial for ageing, a proven treatment is the logical next step. Even if the results of TAME trial are that the overall effect on ageing is small, the precedent has been formed.

As Dr Barzilai put it ‘…Aging is the mother of diseases.’ Once global regulatory agencies agree, the funding and research opportunities will explode.

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