TAME Trial May Set Anti-Aging Drug Precedent

An FDA-approved drug has been used successfully to treat type 2 diabetes for more than 60 years. Studies have already shown that it can slow aging in animals, if they're not already too old. Therefore, the question that jumps to mind is whether it may promote healthy aging in humans, enabling us to live longer. The drug is Metformin.

Finding the answer is the goal of the TAME (Targeting Aging with Metformin) clinical trial. TAME is planned to be a series of six-year clinical trials at 14 leading research institutions across the United States. And it “will engage over 3,000 individuals between the ages of 65-79 … to provide proof-of-concept that aging can be treated, just as we treat diseases.”

The Washington Post explains that “Metformin works on several metabolic and cellular processes linked to aging, including inflammation, waning chromosome repair, metabolic and immune dysfunction, and it improves the efficiency of the mitochondria, the ‘powerhouses’ within cells that drive respiration and energy.”

See “Metformin and Aging: A Review” (2019), published in Gerontology. One 2014 study published in Diabetes, Obesity and Metabolism has shown promising indications that diabetics who take Metformin live longer than non-diabetics who do not.

The TAME trial is led by Nir Barzilai, director of the Institute for Aging Research at the Albert Einstein College of Medicine. Barzilai, who has long championed the life-lengthening powers of Metformin, has been taking it himself since 2015 after being diagnosed with pre-diabetes. However, he urges caution while waiting for the TAME results. “I wouldn’t recommend it to anyone until there is evidence from a clinical trial,” he told The Washington Post.

A research paper is published in Aging Medicine (December 2020). It notes that TAME “may make metformin the first approved drug for anti‐aging, but, more importantly, since it is not testing metformin against a single disease but a collection of age‐related ones, it establishes aging as a medical condition that can be intervened or treated instead of an irreversible process outside human control.”

The Washington Post echoes this important consideration. Since aging is not considered a disease, the FDA is unlikely to approve a drug for its anti-aging effects. But Metformin (an existing, approved, and long-used drug) could now be shown to prevent or delay age-related diseases such as dementia, heart disease, frailty, or cancer. In doing so, Metformin could slow the process of aging and extend life. If so, the FDA and drug makers could warm up to the concept that aging is a disease that should be cured.

Widespread acceptance of this revolutionary concept would be, I think, a game changer. It would open the door to visionary life extension research projects that are too politically incorrect to pursue at this moment. Maybe 20 years from now, we'll have several FDA approved anti-aging drugs. They might function like Metformin, or like other promising drugs that target senescent cells.

The American Foundation for Aging Research (AFAR) is seeking donors to fund TAME with $42 million. $11 million have been raised so far. “If the TAME Trial is successful, and aging is made an indication for treatment, a new era of treatments will be available,” reads the fundraiser.