The formulation is branded as Perceptiv and is marketed by Sevo Nutraceuticals, which licensed it from the University of Massachusetts Lowell, where research Dr Thomas Shea works. Shea developed the formula over a period of years and has conducted trials, some with the support of the Alzheimer’s Association, starting in 2008.
The formula consists of a blend of vitamin E, folic acid and vitamin B12 with 1500 mg of a proprietary blend added on that consists of n-acetyl l-cysteine, acetyl l-carnitine and SAMe. Shea said the proportions of the blend are important (600 mg, 500 mg and 400 mg of the ingredients, respectively), and the research program for the formula set out to prove its synergistic effects, something he believes has been accomplished.
“The new results are incredibly exciting because people showed significant improvement over the course of a year. The formula has been previously studied for people with Alzheimer’s and now it has been shown to have similar effects for people with mild cognitive impairment,” Shea said. The formula has also been studied with participants with no known cognitive impairment and showed good results there, also, he said.
Study details
Shea and his fellow researchers enrolled 34 participants whose age averaged 66 and split them into a 22-member group receiving the formulation and 12 who got a placebo. Participants completed a Dementia Rating Scale questionnaire at baseline and at 3 month intervals up to 12 months. They also participated in the CLOX-1 test at the same interval (example pictured). This simple test has an important endpoint, Shea said, because it involves executive function, rather than other tests such as memorizing strings of words which test only simple memory.
“Drawing a clock from memory is simple, until suddenly you can’t do it anymore,” Shea said. “You have to picture the clock in your mind’s eye, where the numbers and hands go, and then draw it. It’s another step involving other parts of the brain.”
The study was structured as a 6-month trial, with a 6-month open label extension, during which time the placebo group received the intervention as well. The Perceptiv group improved in DRS scale and maintained their performance on CLOX-1, while the placebo group did not improve on the DRS scale and declined in CLOX-1. After also receiving the intervention, the placebo group also improved in DRS and stopped declining in the clock drawing test. The researchers said that 67% of the intervention group that improved or stayed level on their cognitive scores also maintained or improved their performance on the clock test, whereas the same was true for only 18% of the placebo group.
The researches said the latest data “demonstrate efficacy of (the nutritional formulation) for improvement in overall cognitive performance as quantified in the DRS and maintenance of executive function as quantified by CLOX-1 for as long as one year for individuals with Mild Cognitive Impairment.”
Label claims
Some of Shea’s previous work on the formula was conducted on individuals with full-blown Alzheimer’s. While the formula showed positive results, its not information that is of much use when marketing the product as a dietary supplement. These new results can be used to support a cognitive health structure function claim. Shea said this is true even thought the relationship of diagnoses such as Mild Cognitive Impairment or Age Related Cognitive Decline and the subsequent development of Alzheimer’s is poorly understood.
“About half of individuals diagnosed with Mile Cognitive Impairment go on to develop full blown Alzheimer’s and many of the others would, too, if they lived long enough. The term ‘Mild Cognitive Impairment’ came about because of the reluctance of physicians to tell their patients they have Alzheimer’s when it was very mild,” Shea said.
But Shea said the good news is that this latest evidence bolsters the idea that lifestyle interventions such as diet, exercise and appropriate supplementation can help arrest the cognitive decline that many elderly consumer experience.
“Unfortunately, drugs that are effective for Alzheimer’s disease are not good for us prior to manifestation of Alzheimer’s disease, and therefore can’t be used as a preventitive. Supplementation is awesome because you can use it as a preventive,” he said.
Source: J Alzheimers Dis.
2015 Sep 4 (epub ahead of print)
Authors: Remington R, Lortie JJ, Hoffman H, Page R, Morrell C, Shea T.