The Miami-based startup is a spin out of the International Center for Biomedicine led by Nobel-prize nominated neuroscientist Dr. Ricardo Maccioni who has dedicated his life’s work to untangling the source of cognitive decline.
"Within the intricate workings of the brain, tau protein is crucial for maintaining nerve cell structure and function, " Dr. Maccioni explained. “Durabrain works as a brain healthy aging nutrient by supporting normal tau protein function and fostering optimal neural communication."
A blend of Andean shilajit and B vitamins, the dietary supplement launched into the U.S. market last month as a daily boost for the naturally aging brain in support of improved memory, clarity, focus and mood.
The brainchild of a neuroscientist
In the 2000s, Dr. Maccioni proposed his unified theory of neuroimmunomodulation. The culmination of 30 years of Alzheimer’s research, the theory postulates that it is chronic inflammation in the brain that drives progressive synaptic loss and cognitive decline.
This is contrasted with the widely validated amyloid cascade hypothesis that has driven much of the drug development since the mid-1990s, which proposes that it is the production of the amyloid beta peptide and the formation of deposits in the brain that trigger neurodegenerative processes.
“Essentially what we say is that Alzheimer’s is a neuroinflammatory disease with inflammatory patterns at the brain level,” Dr. Maccioni said. “That causes the tau protein to become phosphorylated and modified and then begins to form filaments. Those filaments are the ones that ultimately cause the neuronal death that Alzheimer’s disease entails.”
Noting the failure of traditional pharmacological treatments, his lab began to focus on the underlying inflammatory processes in the context of an alternative multitarget therapy. This approach includes lifestyle adjustments, novel screening programs and dietary supplementation for cognitive wellness.
Mining the Atacama Desert for brain health
The main ingredient in Durabrain is Andean shilajit, a powerful antioxidant phytocomplex formed over the course of centuries by the gradual decomposition of organic matter. Rich in trace minerals like selenium and humic substances like fulvic acid, it has been shown to combat inflammation and boost immune response to provide neuroprotective effects.
Traditionally, shilajit (which means “the destroyer of weakness” in Sanskrit) has been harvested from the Himalayan Mountains and used by inhabitants of Nepal and Northern India to treat a wide variety of conditions ranging from diabetes and altitude sickness to digestive and nervous disorders. Arandi Health mines its shilajit from designated mine sites in the Atacama Desert—a cold, barren plateau west of the Andes Mountains—and exports it for testing, mixing and encapsulation at a manufacturing facility in Miami.
“Extensive research over the last 10 years has shown that precise doses of Andean shilajit combined with vitamins B6, B9 and B12 consistently demonstrated the capacity to maintain normal tau protein structures, which a lifetime of research has found to be a key indicator of cognitive performance and brain health,” said Ignacio Soto, CEO at Arandi Health.
More recently, the Maccioni lab has published findings from a Phase II clinical trial showing that a daily dose of the Durabrain formula improved key aspects of cognitive function over a 24-week follow-up period in individuals with signs of mild to moderate cognitive impairment. The research also continues to explore the functional and neuroprotective role of different Andean shilajit fractions and the molecular mechanisms at work.