The patent, titled “Over-the-Counter Vitamin/Nutraceutical Formulation that Provides Neuroprotection and Maintains or Improves Cognitive Performance” was awarded on December 3, 2013 to UMass Lowell on the work done by Shea and his team. Shea is the director of the Center for Cellular Neurobiology and Neurodegeneration Research at the university.
The patent has been a long time coming, Shea said. The researchers identified a suite of ingredients they felt could effectively address the needs of patients with age related cognitive decline, and then set out to refine the formulation. Once that was fixed, the research on the finished product began, much of which was funded by the Alzheimer’s Associaton. By contrast, many dietary supplements are assembled in a “one from column A, two from column B” approach, Shea said. Many of these ingredients may have clinical backing on their effects in isolation, but very few dietary supplements have what Perceptiv has, that is, research backing the effect of the finished formulation.
“It’s a fair thing to say that we have been working on this formulation for just under 20 years. The actual clinical studies with the supplement started in 2006,” Shea told NutraIngredients-USA.
“I can’t find a product that has data like we have. Most products would cite a study, for example, showing vitamin E is good for you,” he said. “We done seven studies, with over 350 people. It’s been effective in all of our studies, very significant improvement and no adverse events.”
“All of our studies were independently sponsored,” Shea said. “Neither Sevo Nutraceuticals (the exclusive licensee of the product) nor any other company funded the research. That’s very independent work, not the sort that you usually see.”
The most recent research on the formulation was presented at the Alzheimers Association meeting in July in Boston. It showed that Perceptiv, which is a blend of vitamin E, folic acid, vitamin B12 and a proprietary blend of N-acetyl L-cysteine, acetyl L-carnitine and S-adenosyl methionine (SAMe), showed postivie results on cognitive performance for impaired individuals.
“The dementia rating scale is broken down to four categories: cognitively intact, mild, moderate and severe. With people coming into the study, the average was moderate. After three months (of intervention with Perceptiv) the average was mild,” Shea said.
Clinical studies with Shea's team have thus far been confined to cognition and mood. However, published laboratory studies have demonstrated that the formulation reduces oxidative damage to brain tissue, reduces generation of beta amyloid (the toxic protein associated by the neuron death and plaque formation associated with Alzheimer's) and maintains the production of the neutrotransmitter acetylcholine.
Perceptiv is currently marketed through pharmacies and independent natural channel stores. And Emerson Ecologics recently picked up the supplement for distribution through the practitioner channel.